Peritoneal dialysis (PD) has important disadvantages compared to hemodialysis, including low plasma clearance and limited technique survival. A new device for sorbent-assisted (continuous flow) peritoneal dialysis (SAPD) has been designed that is based on continuous recirculation of peritoneal dialysate via a single-lumen peritoneal catheter with regeneration of spent dialysate by sorbents. SAPD treatment may enhance plasma clearance of uremic solutes by increasing the mass transfer area coefficient and maintenance of a high plasma-to-dialysate concentration gradient. In addition, SAPD treatment may preserve integrity of the peritoneal membrane for a longer period of time by avoiding the need for high initial glucose concentrations and by reducing the number of exchanges and (dis)connections of the peritoneal catheter, which may lower the risk of peritonitis. The primary aim of this first-in-human clinical trial is to evaluate the (short-term) clinical safety and performance of SAPD treatment in a small group (n = 12) of stable adult PD patients in a clinical setting (proof of concept). Key secondary objectives include an evaluation of efficacy in terms of plasma clearance, ultrafiltration, and patient tolerance.
Introduction and aim of the study. The centralized preparation and distribution system of acidic concentrate represents a true innovation in hemodialysis, when compared to acid bags, in terms of convenience and eco-sustainability. The aim of this study is to compare the use of traditional acid bags with the centralized distribution system of acidic concentrate, with particular attention to differences in terms of eco-sustainability and convenience. Methods. At the Nephrology Dialysis and Renal Transplantation Unit of the University Hospital of Modena was installed the Granumix system® (Fresenius Medical Care, Bad Homburg, Germany). Data collected before the introduction of the Granumix® system (including the used acid bags, boxes and pallets used for their packaging, liters of acid solution used and kilograms of waste generated from wood, plastic, cardboard and residual acid solution) were compared with those collected after the implementation of the Granumix® system. Factors such as material consumption, volume of waste generated, unused and wasted products, time required for dialysis session preparation and nurses' satisfaction were analyzed to document which system was more environmentally sustainable. Results. Data collected in 2019 at our Dialysis Center showed a consumption of 30,000 acid bags, which generated over 20,000 kg of waste from wood, plastic and cardboard, and approximately 12,000 liters of residual acid solution to be disposed of, with a handling weight by operators reaching nearly 160,000 kg. The use of the centralized distribution system of acidic concentrate resulted in a significant reduction in waste generated (2,642 kg vs 13,617 kg), residual acid solution to be disposed of (2,351 liters vs 12,100 liters) and weights handled by operators (71,522 kg vs 158,117 kg). Conclusions. The acidic concentrate appears to be better suited to the sustainability challenge that dialysis must faces today, particularly due to the significant increase in the number of patients, which leads to a higher number of treatments and, therefore, a growing demand for eco-sustainable products.
Abstract Background and Aims Dialysate is produced by mixing ultra-purified water with acid and bicarbonate concentrates. Acidic concentrate for hemodialysis can be supplied to the dialysis machine through single-use bags or central concentrate supply. Central delivery of acid concentrate represents an innovation in hemodialysis settings in terms of practicality and eco-sustainability as this system is able to produce and distribute ready-to-use acid dialysis concentrate without the use of acid concentrate bags. The aim of our study was to compare the amount of material (including packaging) used to supply acid concentrate using a single-use bag (3.8 L or 4.5 L) or central acid supply at the Nephrology Dialysis and Renal Transplant Unit of Azienda Ospedaliero Universitaria di Modena, Modena, Italy. In particular, we reviewed the amount of consumable material before (January-December 2019) and after the implementation of central concentrate supply (July 2022-June 2023). Lastly, a survey was delivered to all dialysis nurses who work in our dialysis Center to evaluate their feedback on central concentrate supply. Method Our center is equipped with 46 dialysis stations for patients on chronic hemodialysis that in 2019 delivered 30 000 hemodialysis treatments distributed across morning, afternoon, and evening shifts. Granumix system® (Fresenius Medical Care, Bad Homburg, Germany) was installed in 2022. It produces and distributes acid concentrate fluid with two different concentrations of K+ (2 and 3 mEq/L) and a unique concentration of Ca2+ 1.5 mmol/L (see Figure). Results The data collected in 2019 at our Dialysis Center showed that 30 000 acid bags corresponding to 121 000 L of acid concentrate fluid were used to perform hemodialysis. Utilization of bags generated 3 750 kg of pallets, 4 500 kg of plastic and 5 367 kg of boxes. Considering that approximately 10% of the acid concentrate fluid remains unused during each dialysis treatment, approximately 12 000 L of unutilized acid concentrate fluid was wasted. Following the introduction of the Granumix® system, there was a significant reduction (−80.6%) in the utilization of single-use acid concentrate bags (n = 5 805) and, consequently, in the use of boxes (n = 2 294 vs. n = 11 667) and pallets (n = 40 vs. n = 208). The centralized distribution system of acid concentrate led to a significant reduction in waste including boxed, plastic and pallets (2 642 kg vs. 13 617 kg), disposal of residual acidic solution (2 351 liters vs. 12 100 liters), and handling of materials by dialysis staff (37 522 kg vs. 158 117 kg). Another advantage of this system is the optimized usage of acid concentrate fluid. This system ensures that only the required amount of acid for a specific treatment is used, effectively minimizing waste and decreasing the production of special waste. The results of the survey (response rate 75%) documented that 79.5% of the nurses received adequate training for its use; 94.9% experienced a reduction in fatigue and 84.6% declared that had more time to dedicate to patients. Lastly, the survey showed that 96.4% of the participants were completely satisfied with the implementation of this new system. Conclusion Central delivery of acid concentrate is an innovative solution with eco-sustainable potentialities in reducing the consumable materials and workload in hemodialysis. Overall, most nurses expressed satisfaction as this system reduces dialysis staff workload and allows more time for patient care.
Abstract Background and Aims Peritoneal dialysis has important disadvantages, including low plasma clearance and a limited technique survival. A new device for sorbent-assisted continuous flow peritoneal dialysis has been designed (Wearable Artificial KIDney, WEAKID) that is based on continuous recirculation (rapid cycling) of peritoneal dialysate via a single-lumen peritoneal catheter with regeneration of dialysate using sorbents. Anticipated benefits are a better plasma clearance a higher mass transfer area coefficient with continuous flow of dialysate and enhanced diffusion due to a higher time-averaged plasma-dialysate concentration gradient with sorbent-based dialysate regeneration, and a prolonged technique survival thanks to lower peritonitis risk (less (dis)connections) and a lower glucose exposure. Method This is a first-in-human, prospective, open-label, non-randomized, single-arm, multicenter study, that will be performed at the University Medical Center Utrecht (Utrecht, The Netherlands), Università degli studi di Modena e Reggio Emilia (Italy), and Instituto de Investigación Hospital Universitario La Paz, Servicio Madrileño de Salud (Spain). We aim to include 12 stable, adult PD patients. In the first week, blood, urine, and dialysate samples will be collected over three separate days to assess the efficacy of the patient's standard PD schedule. The WEAKID system will then be tested in a clinical setting on 6 days over a period of 2 weeks (three consecutive days per week). During the first week, participants will be treated with WEAKID without sorbents for 4h (first day) or 8h (second and third day). The second week, treatment will consist of WEAKID with sorbents for 4h (first day) or 8h (second and third day). This way, exposure to new components of the system is incremental and the effectiveness of continuous recirculation of dialysate and that the added effect of sorbent-based dialysate regeneration can be analyzed separately. Outcomes The primary aim of this first-in-human clinical trial is to evaluate the (short term) clinical safety and performance of WEAKID treatment in a clinical setting. The primary safety objective will be assessed by describing and examining the incidence of: Key secondary objectives include an evaluation of efficacy in terms of plasma clearance, ultrafiltration, net base release, and patient tolerance. Planning Inclusion of the first patient is expected in January 2024, the final inclusion is expected to take place in November 2024.
Abstract Background and Aims Peritonitis is a common and serious complication of peritoneal dialysis (PD). A single episode of severe peritonitis or multiple peritonitis episodes frequently leads to diminished peritoneal ultrafiltration capacity, hospitalization, and a switch to hemodialysis. Prevention of infection is the mainstay for the reduction of peritonitis rate. According to the current guidelines, we use nasal antibiotic prophylaxis if patients are identified as nasal Staphylococcus aureus carriers on screening prior to PD beginning. Eradication of S. aureus Regular with nasal mupirocin reduces the rate of exit-site infections but has uncertain effects on the risk of peritonitis. The aim of this study was to evaluate the rate of S. aureus peritonitis in our cohort of patients receiving PD. Method A retrospective single-center study was conducted in a large Italian PD center. We reviewed all cases of bacterial peritonitis from 1999 to 2023. Demographic and clinical characteristics of the patients and microbiological features of the bacteria identified in cultures were extracted from electronic health record. From 2011, all patients were screened before surgery for Methicillin-resistant S. aureus (MRSA) and methicillin-sensitive S. aureus (MSSA) with nares swabs. All patients with positive nasal colonization for MSSA and MRSA were treated with nasal mupirocin (nasal ointment twice daily for 5 consecutive days every 4 weeks) until eradication was confirmed by a nasal swab. According to our protocol, from 2011, screening for S. aureus carriage along peritoneal fluid culture was performed in all patients on PD with an episode of peritonitis to verify nasal colonization with S. aureus. The study was approved by the regional ethical committee of Emilia Romagna (507/2021/OSS/AOUMO SIRER ID 2845). Results Overall, 345 cases of peritonitis were reviewed in 214 patients who received peritoneal dialysis. In our center, the rate of peritonitis was 0.23 episodes/patient-year. After the introduction of nasal screening for S. aureus carriage, the episodes of S. aureus peritonitis decreased in frequency (0.0093 episodes/patient-year vs. 0.034 episodes/patient-year) and as absolute number (17.8% vs 3.6%; p = 0.001). No differences were observed in the rate of catheter removal in the two populations (p = 0.99). The age of 109 patients screened for S. aureus carriage was 64.1 ± 17 years. Males accounted for 58.9% and automated PD (APD) was chosen by 66% of the subjects. After an average period of 1.6 years from the start of PD, 7 patients experienced S. aureus peritonitis in the absence of exit-site or tunnel catheter infection. Nasal screening at the time of peritonitis showed that half of them were carriers of S. aureus and half were negative (one patient was not screened). Colonization from S. aureus was found in another 9 patients whose peritonitis was caused by a different type of bacteria (44% S. epidermidis, 33.3% Enterobacteriaceae, 11.1% Acinetobacter, and 11.1% culture-negative peritonitis). Conclusion Our data document that screening for S. aureus, along with other preventive measures, contributes to significantly reducing the rate of S. aureus peritonitis in patients screened and treated for S. aureus carriage at the time of PD start. Routine screening and the use of a mask during connection are required because recolonization occurs frequently in this population.
Abstract Background and Aims Chronic kidney disease is a growing problem worldwide with a growing number of patients requiring kidney replacement therapy. In recent years we have developed a novel device for peritoneal dialysis (PD), the WEarable Artificial KIDney (WEAKID); composed of a wearable device connected to a dialysate reservoir. WEAKID uses both sorbent technology and continuous flow PD to improve dialysis efficacy. Formative usability testing aids to the identification of design issues that may interfere with a device's safe and effective use and thus may influence decisions made in the design process. Here, we present the results of an international, multicentre, formative usability study of WEAKID among nurses and patients. Method This study used a mixed-methods design and was conducted in hospitals in Italy (Modena University Hospital), Spain (La Paz University Hospital, Madrid), and the Netherlands (University Medical Center Utrecht) between November 2021 and December 2022. An individual, formative usability testing session was conducted with each participant (nurse or patient) under the conditions of simulated use. Participants were asked to perform basic operational procedures (i.e. turning the device on/off, input of dialysis settings, handling an alarm) with the device according to a usability task list. Their performance was observed and use errors (i.e., something that a participant does or fails to do that results in an unexpected or unintended outcome) were noted. Furthermore, participants were asked for feedback, both verbally and by means of completing the system usability scale (SUS), reflecting perceived usability on a scale from 0 (worst) to 100 (best). Results We included 14 participants (n = 6 nurses, n = 8 patients) in three participating centres. All nurses were female and had a median experience with PD of 20.5 years (range 0.5-32). Patients were generally highly educated (n = 5, 63%). In total, 22 use errors occurred, 10 in nurses and 12 in patients. These use errors included factors not related to the device, e.g. not taking appropriate hygiene measures. In particular, use errors occurred during the priming/connection of catheter and handling the alarm. Participants’ feedback mainly concerned the small screen (and thus font) size, user interface (e.g. lack of colour-coded soft buttons), and (short) length of the patient line. The mean SUS score was 70 (range 57.5–85) for nurses, and 71.9 (range 55–87.5) for patients. Conclusion Despite the slightly above-average perceived usability of the device's current design stage, participants made a lot of suggestions for improvements, and usability must be improved to make the device ready for market introduction.
BACKGROUND:Telemedicine has been widely used to deliver healthcare to outpatients during the COVID-19 pandemic. The effectiveness of this modality is unclear in patients with a pre-dialysis stage of chronic kidney disease (CKD). This study aims to describe the clinical characteristics and management of CKD patients receiving telemedicine care during the COVID-19 pandemic. MATERIALS AND METHODS:A retrospective single-center cohort study enrolled outpatients with pre-dialytic stage of CKD from March 9 to June 21, 2020. Telemedicine was proposed for all patients with a stable CKD to reduce the risk of in-hospital transmission whereas in-person visit was performed for patients requiring urgent evaluation. RESULTS:In a 15-week period, 97 patients received 116 nephrological visits. According to the modality of healthcare delivery, the patients were subdivided into telemedicine (66%) and in-person visit (34%) groups. Mean age of all CKD patients was 72.8 ± 12.5 years and males were 50.5% of the population. The average estimated glomerular filtration rate (eGFR) was 14.6 ± 6 mL/min. Patients evaluated by telemedicine had better kidney function (GFR, 16.2 ± 6.4 vs. 13.6 ± 5.9 mL/min/1.73m2; p = 0.037), a lower body mass index (BMI) (24.1 ± 1.7 vs. 30.6 ± 5.7; p = 0.019), and a lower risk of CKD progression (51.1 vs. 25.4%, p = 0.017) than patients requiring in-person visit. Telemedicine-visit patients experienced a significantly lower number of pharmacological changes than patients managed in the ambulatory setting. Telemedicine was also used to conduct 20% of educational meetings on the choice of dialysis modality and 18.9% of pre-eligibility visits for kidney transplantation. CONCLUSION:Telemedicine made it possible to provide care to and maintain close monitoring of 2/3 of patients with pre-dialytic stage of CKD during the COVID-19 pandemic.
Since primary membranous nephropathy is a heterogeneous disease with variable outcomes and multiple possible therapeutic approaches, all 13 Nephrology Units of the Italian region Emilia Romagna decided to analyze their experience in the management of this challenging glomerular disease. We retrospectively studied 205 consecutive adult patients affected by biopsy-proven primary membranous nephropathy, recruited from January 2010 through December 2017. The primary outcome was patient and renal survival. The secondary outcome was the rate of complete remission and partial remission of proteinuria. Relapse incidence, treatment patterns and adverse events were also assessed. Median (IQR) follow-up was 36 (24–60) months. Overall patient and renal survival were 87.4
Background The weakened immune system of patients on hemodialysis (HD) may prolong SARS-CoV-2 infection compared to the general population. Current international guidelines recommend ending isolation in conjunction with serial testing in moderately and severely immunocompromised subjects. This study aimed to estimate SARS-CoV-2 infectivity by measuring RT-PCR test positivity in HD patients. A comparison between RT-PCR test and cycle threshold (Ct) value has been performed as a secondary endpoint. Methods A single-center retrospective study was conducted at the University of Modena (Italy) from March 2020 to October 2022. Only patients on chronic HD therapy with COVID-19 were enrolled in the study. In our HD Center, two negative nasopharyngeal reverse transcription polymerase chain reaction (RT-PCR) results were used to end quarantine in this population. SARS-CoV-2 RT-PCR test positivity duration measured the time elapsed from a positive RT-PCR to a second negative test. Ct cut-off of 35 cycles was used to definite “high Ct value,” a condition characterized by a large number of cycles of PCR amplification to register a positive RT-PCR test. Results During the observational period, 159 cases of SARS-CoV-2 infections were diagnosed in 151 patients. Median age was 70.1 (54.3–81.6) years and males accounted for 59.6% of the COVID-19 population. Median duration of SARS-CoV-2 RT-PCR test positivity on the nasal mucosa accounted for 30 (IQR, 21–40.5) days. Unvaccinated patients experienced significantly longer RT-PCR test positivity compared to vaccinated patients (42 [IQR,31–56] vs. 28 [IQR,20–35.7] days; p = < 0.001). The use of high Ct value, a laboratory surrogate of SARS-CoV-2 replication, anticipated a negative RT-PCR test of 9 (IQR, 6–12) days. Multivariate linear regression analysis showed that increased age ( β coefficient 0.31; confidence interval [CI] 95%, 0.14—0.43; p = < 0.001) and the lack of anti-SARS-CoV-2 vaccination ( β 0.49 CI95%, 11.9–22.5; p = < 0.001) were predictors of a prolonged RT-PCR positivity. Conclusions Patients with COVID-19 on HD had prolonged RT-PCR test positivity. The adoption of “high Ct value” criteria led to a significant reduction in the duration of RT-PCR test positivity compared to the use of the classical nucleic acid amplification test. In our study, the lack of SARS-CoV-2 vaccination and older age were independently associated with a longer RT-PCR positivity.
Abstract BACKGROUND AND AIMS Although discontinuation of antiplatelet agents at least 5 days before kidney biopsy is recommended by most guidelines and commonly advised by nephrologists, the evidence behind this practice is very low. Indeed, few non-randomized studies previously showed a similar rate of bleeding after kidney biopsy in patients who received aspirin and those who did not. Withdrawal of antiplatelet agents has been associated with an immediate and substantial increase in cardiovascular events, especially in patients at risk for coronary heart disease. METHOD We conducted a single centre retrospective cross-sectional study comparing the risk of complications after percutaneous ultrasound-assisted native kidney biopsy in patients who received antiplatelet agents within 5 days from biopsy and those who did not; the study was approved by local Ethical Committee (protocol 1321/2020/OSS*/AOUMO). The main outcome was the difference in the proportion of major complications (any of the following: red blood cells transfusion, need for selective arterial embolization, surgical revision, nephrectomy). Secondary outcomes were: difference in the proportion of minor complications (drop in haemoglobin >2 g/dL, bladder tamponade, macrohematuria, need for angio-CT scan, hematoma >3 cm), difference in the proportion of complications between patients who received antiplatelet agents within 48 h and those who received them within 3–5 days from biopsy, identification of independent factors predictive of major complication. RESULTS We analszed 769 percutaneous native kidney biopsies performed by nephrologists from 1 January 2010 to 31 December 2020 in 741 patients; 113 procedures (14.69%) were conducted under antiplatelet therapy (within 5 days from biopsy). Demographical, clinical and laboratory characteristics of the whole cohort and dividing patients according to antiplatelet therapy status (absent or within 5 days from biopsy) are reported in Table 1; most patients (83.17%) on antiplatelet were receiving low-dose aspirin. A single (or a combination of more) major complication occurred in 17/656 (2.59%) of patients without and in 4/113 (3.54%) patients with antiplatelet therapy, with non-significant difference between groups (percentage point difference 1%, 95% CI –2% to 4%, P = .57); no deaths were attributable to the biopsy procedure. There were 103/656 (15.7%) minor complications in patients without and 14/113 (12.39%) in patients with antiplatelet therapy, with non-significant difference between groups (percentage point difference 3%, 95% CI –10% to 4%, P = .37). In patients treated with antiplatelet within 5 days from biopsy, we encountered no significant difference in the proportion of major or minor complications in those who received therapy in the last 48 h or 3–5 days before the procedure. The final multivariate stepwise logistic regression model for the prediction of major complication included two variables (platelets <120*10^3, eGFR); the model was logit(p) = –2668 + 2383*(platelets < 120*10^3)-0036*eGFR, where P is the probability of having a major complication after kidney biopsy (see Table 2 for univariate and multivariate analysis). This model produced an AUC of 0808 (95% CI 0.724–0.89). CONCLUSION Receiving anti-platelet therapy (in particular, low-dose aspirin) within 5 days from percutaneous native kidney biopsy did not increase the risk of major or minor complications in our cohort. Platelet count < 120*10^3/µL and lower eGFR were significantly associated with an increased risk for major complication.
Abstract BACKGROUND AND AIMS mRNA-1273 vaccine (previously known as vaccine Moderna) has shown 94.1% efficacy at preventing COVID-19 illness in the general population. Vaccine-related adverse events (AEs) were usually mild or moderate in intensity and resolved within a few days. Nevertheless, the fear of developing AEs led some patients on haemodialysis to deny vaccination or additional booster doses. No studies have been conducted to evaluate the reactogenicity of the mRNA-1273 vaccine in dialysis patients. To inform public health and clinical practice, we investigated the safety of the mRNA-1273 vaccine in a cohort of patients on haemodialysis. METHOD We conducted a retrospective analysis of in-centre haemodialysis patients without a prior COVID-19 diagnosis who underwent mRNA-1273 vaccine from 1 March to 30 April 2021. mRNA-1273 vaccine was performed in all patients without signs of ongoing infection or COVID-19 who provided written consent from 24 March to 30 April 2021. AEs occurring after the first and the second doses were collected and classified as local or systemic. RESULTS Overall, 126 patients on chronic maintenance dialysis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54.7–76) years and 53.6% of patients were aged ≥65 years (Table 1). AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%). The rates of local AEs were similar after the first and second doses (P = .8), whereas systemic AEs occurred more frequently after the second dose (P = .001). Fever (P = .03), fatigue (P = .02) and nausea/vomiting (P = .03) were significantly more frequent after the second dose of the vaccine (Figure 1). Analysis of the data detected statistically significant differences in duration of axillary swelling/tenderness (P = .07) and diarrhoea (P = .02) between the first and second. In both cases, these symptoms lasted longer after the second dose of the vaccine. There were no age-related differences in the rate of AEs between older (≥65 years) and younger participants (18–64 years). Lastly, we noted a lower rate of AEs in hemodialysis patients after the first dose (57.9% versus 84.2%) and second doses (61.9% versus 88.6%) compared to the general population. CONCLUSION RNA-1273 vaccine was associated with the development of transient AEs after the first (57.9%) and second doses (61.9%) in patients on haemodialysis. Systemic AEs were more common after the second dose than the first dose of vaccine. The duration of AEs lasted for a few days, without any apparent consequences. These data confirm the safety of the RNA-1273 vaccine in haemodialysis patients and support the promotion of COVID-19 vaccination in hesitant patients.
Introduction: Some hemodialysis patients are reluctant to undergo COVID-19 vaccination for the fear of developing adverse events (AEs). The aim of this study was to verify the safety of the mRNA-1273 vaccine in hemodialysis patients. Methods: We conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1st to April 30th, 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic. Results: Overall, 126 patients on chronic maintenance dialysis without a prior COVID-19 diagnosis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged ≥65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%). The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of the vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem to be lower than in the general population. Conclusion: The RNA-1273 vaccine was associated with the development of transient AEs after the first and second doses in patients on chronic maintenance hemodialysis. They were mostly local, whereas systemic AEs were more prevalent after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae.
Introduction . Patients receiving in-center hemodialysis are extremely vulnerable to COVID-19. It is unclear if routine screening of asymptomatic hemodialysis patients is an effective strategy to prevent COVID-19 outbreaks within the dialysis unit. Methods . We conducted a retrospective analysis of in-center hemodialysis patients who underwent bimonthly COVID-19 rapid antigen test screening from February 15 th to December 26 th , 2021. Nasal rapid antigen testing was performed in all asymptomatic patients. All rapid antigen-positive tests were confirmed by RT-PCR nasopharyngeal swab. Besides universal rapid antigen screening, RT-PCR testing was conducted in all symptomatic patients and contacts of COVID-19 subjects. Results . Overall, 4079 rapid antigen tests were performed in 277 hemodialysis patients on chronic hemodialysis with a mean age of 68.4 ± 14.6 years. Thirty-eight (0.9%) rapid antigen tests resulted positive. Only five (13.8%) positive-rapid antigen tests were also positive by RT-PCR testing. During the same period, 219 patients regularly screened by rapid antigen tests bimonthly underwent 442 RT-PCR nasopharyngeal swabs for clinical reasons. RT-PCR testing yielded a positive result in 13 (5.9%) patients. The time elapsed between PCR and the negative-rapid antigen test was 7.7 ± 4.6 days (range 1.8–13.9 days). At the end of the follow-up, 6.4% of the population on in-center hemodialysis contracted COVID-19, and routine rapid antigen tests detected only 5 out of 18 (27.7%) COVID-19 cases. No outbreaks of COVID-19 were identified within the dialysis unit. Conclusion . Bimonthly rapid antigen screening led to the early diagnosis of COVID-19 in less than one-third of cases. The short incubation period of the new SARS-CoV-2 variants makes bimonthly test screening inadequate for an early diagnosis of COVID-19. More frequent tests are probably necessary to improve the utility of COVID-19 nasal rapid antigen test in patients on hemodialysis.
Background/Aim: COVID-19 is a concerning issue among in-center hemodialysis (HD) patients. To prevent COVID-19 diffusion in our HD facility, weekly rapid nasal antigen test screening was performed for all asymptomatic patients on chronic HD. This study aimed to assess the performance of weekly rapid antigen test in detecting SARS-CoV-2 infection among asymptomatic patients receiving HD. Patients and Methods: A retrospective analysis was conducted in HD patients who underwent rapid antigen test screening from December 2021 to March 2022. The diagnosis of COVID-19 with rapid antigen test was always confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR). Results: During the observational period, 1,748 rapid antigen tests were performed in 220 HD patients. Mean age was 68.4 +/- 14.6 years. Fifteen (8.5%) patients resulted positive for SARS-CoV-2 infection using rapid antigen tests. The diagnosis was subsequently confirmed in 14 (93.3%) patients by RT-PCR. During the same period, 12 (5.4%) symptomatic patients, regularly screened with weekly rapid antigen test, resulted positive for SARS-CoV-2 infection using RT-PCR. Overall, weekly rapid antigen test screening identified 14 out of 26 (53.8%) COVID-19 cases and showed a positive predictive value of 93%. Conclusion: Weekly antigen test screening of asymptomatic patients on chronic HD detected around half of the COVID-19 cases in our population.
Clinical application of continuous flow peritoneal dialysis (CFPD) has been explored since the 1960s, but despite anticipated clinical benefits, CFPD has failed to gain a foothold in clinical practice, among others due to the typical use of two catheters (or a dual-lumen catheter) and large dialysate volumes required per treatment. Novel systems applying CFPD via the existing single-lumen catheter using rapid dialysate cycling may solve one of these hurdles. Novel on-demand peritoneal dialysate generation systems and sorbent-based peritoneal dialysate regeneration systems may considerably reduce the storage space for peritoneal dialysate and/or the required dialysate volume. This review provides an overview of current evidence on CFPD in vivo. The available (pre)clinical evidence on CFPD is limited to case reports/series with inherently nonuniform study procedures, or studies with a small sample size, short follow-up, and no hard endpoints. Small solute clearance appears to be higher in CFPD compared to conventional PD, in particular at dialysate flows >= 100 mL/min using two single-lumen catheters or a double-lumen catheter. Results of CFPD using rapid cycling via a single-lumen catheter are too preliminary to draw any conclusions. Continuous addition of glucose to dialysate with CFPD appears to be effective in reducing the maximum intraperitoneal glucose concentration while increasing ultrafiltration efficiency (mL/g absorbed glucose). Patient tolerance may be an issue since abdominal discomfort and sterile peritonitis were reported with continuous circulation of the peritoneal dialysate. Thus, well-designed clinical trials of longer duration and larger sample size, in particular applying CFPD via the existing catheter, are urgently required.
There are limited data on the effects of COVID-19 on peritoneal dialysis (PD) patients. This study aimed to describe the impact of COVID-19 on the PD population. A monocentric retrospective observational study was conducted on 146 consecutive PD patients followed from January 2020 to March 2022 at the University Hospital of Modena, Italy. Twenty-seven (18.4%) PD patients experienced 29 episodes of SARS-CoV-2 infection, corresponding to an incidence rate of 0.16 episodes/patient-year. Median age of COVID-19 patients was 60.4 (interquartile range [IQR] 50.2–66.5) years. In unvaccinated patients (n. 9), COVID-19 was always symptomatic and manifested with fever (100%) and cough (77.7%). COVID-19 caused hospital admission of three (33.3%) patients and two (22.2%) died of septic shock. COVID-19 was symptomatic in 83.3% of vaccinated subjects (n.18) and manifested with fever (61.1%) and cough (55.6%). Hospital admission occurred in 27.8% of the subjects but all were discharged home. Median SARS-CoV-2 shedding was 32 and 26 days in the unvaccinated and vaccinated groups, respectively. At the end of the follow-up, COVID-19 triggered the shift from PD to HD in two subjects without affecting the residual renal function of the remaining patients. Overall, COVID-19 caused an excess death of 22.2%. COVID-19 vaccination refusal accounted for only 1.6% in this cohort of patients. COVID-19 incident rate was 0.16 episodes/patient-year in the PD population. About one-third of the patients were hospitalized for severe infection. Fatal outcome occurred in two (7.4%) unvaccinated patients. A low vaccination refusal rate was observed in this population.
We report the isolation, sequence, and transcriptional behavior of the Drosophila even-skipped (eve) gene, a member of the pair-rule class of segmentation genes. We show that the eve gene contains a homeo box and hence is related structurally to the pair-rule gene fushi tarazu and to homeotic selector genes. However, the eve homeo box differs significantly from those previously described and encodes a putative DNA recognition helix that would probably recognize different sequences. The eve gene resembles other pair-rule genes in showing a transient seven stripe zebra pattern during the blastoderm stage, but seven additional stripes arise soon thereafter. Together, these 14 stripes are required for the activation of coincident stripes of engrailed transcripts, leading to the subdivision of the embryo into compartmental and segmental units.
The process of aging population will inevitably increase age-related comorbidities including chronic kidney disease (CKD). In light of this demographic transition, the lack of an age-adjusted CKD classification may enormously increase the number of new diagnoses of CKD in old subjects with an indolent decline in kidney function. Overdiagnosis of CKD will inevitably lead to important clinical consequences and pronounced negative effects on the health-related quality of life of these patients. Based on these data, an appropriate workup for the diagnosis of CKD is critical in reducing the burden of CKD worldwide. Optimal management of CKD should be based on prevention and reduction of risk factors associated with kidney injury. Once the diagnosis of CKD has been made, an appropriate staging of kidney disease and timely prescriptions of promising nephroprotective drugs (e.g., RAAS, SGLT-2 inhibitors, finerenone) appear crucial to slow down the progression toward end-stage kidney disease (ESKD). The management of elderly, comorbid and frail patients also opens new questions on the appropriate renal replacement therapy for this subset of the population. The non-dialytic management of CKD in old subjects with short life expectancy features as a valid option in patient-centered care programs. Considering the multiple implications of CKD for global public health, this review examines the prevalence, diagnosis and principles of treatment of kidney disease in the aging population.
Safe and timely discontinuation of quarantine of in-center hemodialysis (HD) patients with a previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is a challenging issue for the nephrological community because current guidelines for ending isolation do not mention dialysis patients. To prevent potentially fatal outbreaks of coronavirus disease 2019 (COVID-19), a cautionary approach has been adopted by most dialysis units. The criteria for ending the isolation in the HD population generally coincide with those recommended for immunocompromised people. Thus, a test-based strategy relying on two consecutive negative reverse transcriptase-polymerase chain reaction (RT-PCR) nasopharyngeal swabs has been adopted to terminate quarantine. This strategy has the disadvantage of prolonging isolation as RT-PCR positivity does not equate to SARS-CoV-2 infectivity. Consequentially, prolonged positivity of SARS-CoV-2 results in excessive workload for the HD staff who must face an increasing number of COVID-19 patients requiring isolation. This condition leads also to serious implications for the patients and their households including work productivity loss, postponement of health-care appointments and an increased risk of COVID-19 reinfection. To counteract this problem, other diagnostic tests should be used to provide the best care to HD patients. Recent results seem to encourage the use of RT-PCR cycle threshold (Ct) values and rapid antigen tests given their better correlation with cell culture for SARS-CoV-2 than RT-PCR testing. Here, we provide an overview of the current scientific evidence on the tests used to verify the infectiousness of the virus in order to stimulate the nephrological community to adopt a streamlined and pragmatic procedure to end isolation in COVID-19 patients on HD.
Abstract BACKGROUND AND AIMS A great amount of information has been divulged on the epidemiology and outcome of coronavirus disease 2019 (COVID-19) in patients with ESRD. The majority of the studies have been conducted in patients on maintenance hemodialysis (HD) and kidney transplant recipients. Unfortunately, few studies focused on the outcome of peritoneal dialysis (PD) patients. Information regarding this subset of the population has been extrapolated from aggregated data including a higher percentage of HD patients. As a result, the impact of COVID-19 is indefinite in patients receiving PD. We conducted a study to better understand how patients on PD have been affected by COVID-19. METHOD We conducted a single-center retrospective analysis of 141 PD patients followed at the University Hospital of Modena, Italy from 1 March 2020 to 31 December 2021. The diagnosis of COVID-19 was performed through nasopharyngeal swab RT–PCR testing. Duration of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) shedding measured the time elapsed from diagnosis of COVID-19 to one or two (if available) negative nasopharyngeal PCR tests. Median and interquartile range or mean and standard deviation were used for continuous variables and percentage for categorical variables. A P-value <0.05 was considered statistically significant. RESULTS During the pandemic, 18 out of 141 (12.7%) patients receiving PD dialysis contracted COVID-19. Median age was 60 (50.2–66.5) years with a predominance of males (72.2%) The percentage of patients on APD accounted for 33.3%. The infection was symptomatic in out of 18 (94.4%) patients. Fever (94.4%) and cough (55.6%) were the most common symptoms. Viral shedding, traced with nasopharyngeal swabs lasted 26 (14.5–3.5) days. Two patients were inactive on the waiting list for kidney transplantation for a mean of 43 ± 1.4 days. COVID-19 caused hospital admission of seven (38.9%) patients. During hospitalization two (11.1%) patients switched from PD to HD for ultrafiltration failure and inadequate solute clearance and two (11.1%) died for septic shock with multiorgan failure. In our cohort of patients, excess death due to COVID-19 was 22.2%. Half of the patients contracted the infection before the availability of SARS-CoV-2 vaccine. There were no statistically significant differences between vaccinated and unvaccinated patients in terms of symptoms, viral shedding and hospital admission or (Table 1). We underline that COVID-19 was fatal only in two unvaccinated patients. CONCLUSION This study reports the monocentric experience of a large PD center during the COVID-19 pandemic. COVID-19 was symptomatic in the majority of patients and led to hospitalization of about 40% of the patients. The rate of symptoms, viral shedding and hospital admission was similar between vaccinated and unvaccinated patients. Two unvaccinated patients died for the severe consequence of COVID-19.