JDDG: Journal der Deutschen Dermatologischen GesellschaftVolume 20, Issue 2 p. 206-211 Clinical LetterOpen Access Keine Evidenz für ein erhöhtes Risiko von Herpes zoster mit Indikation zur stationären oder teilstationären Behandlung während des ersten Jahres der COVID-19-Pandemie in Deutschland Sven-Niklas Burmann, Sven-Niklas Burmann Klinik für Dermatologie, Venerologie und Allergologie, HELIOS St. Elisabeth Krankenhaus Oberhausen, Universität Witten-Herdecke, OberhausenSearch for more papers by this authorAndreas Bollmann, Andreas Bollmann Herz-Zentrum der Universität LeipzigSearch for more papers by this authorSven Hohenstein, Sven Hohenstein Herz-Zentrum der Universität LeipzigSearch for more papers by this authorAndreas Meier-Hellmann, Andreas Meier-Hellmann Helios Research Center BerlinSearch for more papers by this authorRalf Kuhlen, Ralf Kuhlen Helios Research Center BerlinSearch for more papers by this authorAlexander Kreuter, Corresponding Author Alexander Kreuter alexander.kreuter@helios-gesundheit.de Klinik für Dermatologie, Venerologie und Allergologie, HELIOS St. Elisabeth Krankenhaus Oberhausen, Universität Witten-Herdecke, Oberhausen Korrespondenzanschrift Prof. Dr. med. Alexander Kreuter Klinik für Dermatologie, Venerologie und Allergologie HELIOS St. Elisabeth Krankenhaus Oberhausen Universität Witten-Herdecke Josefstraße 3 46045 Oberhausen E-Mail: alexander.kreuter@helios-gesundheit.deSearch for more papers by this author Sven-Niklas Burmann, Sven-Niklas Burmann Klinik für Dermatologie, Venerologie und Allergologie, HELIOS St. Elisabeth Krankenhaus Oberhausen, Universität Witten-Herdecke, OberhausenSearch for more papers by this authorAndreas Bollmann, Andreas Bollmann Herz-Zentrum der Universität LeipzigSearch for more papers by this authorSven Hohenstein, Sven Hohenstein Herz-Zentrum der Universität LeipzigSearch for more papers by this authorAndreas Meier-Hellmann, Andreas Meier-Hellmann Helios Research Center BerlinSearch for more papers by this authorRalf Kuhlen, Ralf Kuhlen Helios Research Center BerlinSearch for more papers by this authorAlexander Kreuter, Corresponding Author Alexander Kreuter alexander.kreuter@helios-gesundheit.de Klinik für Dermatologie, Venerologie und Allergologie, HELIOS St. Elisabeth Krankenhaus Oberhausen, Universität Witten-Herdecke, Oberhausen Korrespondenzanschrift Prof. Dr. med. Alexander Kreuter Klinik für Dermatologie, Venerologie und Allergologie HELIOS St. Elisabeth Krankenhaus Oberhausen Universität Witten-Herdecke Josefstraße 3 46045 Oberhausen E-Mail: alexander.kreuter@helios-gesundheit.deSearch for more papers by this author First published: 10 February 2022 https://doi.org/10.1111/ddg.14665_gAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Volume20, Issue2February 2022Pages 206-211 RelatedInformation

Objective The impact of the COVID-19 year on the number of daily psychiatric emergency admissions and length of stay was compared with previous years. Methods In a retrospective study, the four quarters of 2020 of several psychiatric hospitals in Germany were statistically compared with the respective quarters of 2018 and 2019. Results A total of 73,412 cases was analyzed. In the 2 (nd) quarter of 2020, the number of daily admissions was significantly lower as compared to the control period (59.1 vs. 70.7; incidence rate ratio [95 % confidence interval] 0.81 [0.69; 0.96]; p = 0.012). Length of stay was numerically but not significantly different as compared to the control periods. Conclusion The COVID-19 pandemic had a strong impact on inpatient psychiatric care. In the future, multimodal care structures must ensure the care of severely mentally ill people in crisis situations.

Zusammenfassung Ziel der Studie Die Auswirkungen der COVID-19-Pandemie in 2020 auf die Anzahl der täglichen psychiatrischen Notfallaufnahmen und die stationäre psychiatrische Aufenthaltsdauer wurde mit Vorjahren verglichen. Methodik In einer retrospektiven Studie wurden die 4 Quartale 2020 mehrerer psychiatrischer Kliniken in Deutschland mit den jeweiligen Quartalen von 2018 und 2019 statistisch verglichen. Ergebnisse Insgesamt wurden 73 412 Fälle analysiert. Im 2. Quartal 2020 war die Zahl der täglichen Aufnahmen mit 59,1 signifikant niedriger im Vergleich zum Kontrollzeitraum mit 70,7 (Inzidenzratenverhältnis [95 %-Konfidenzintervall] 0,81 [0,69; 0,96]; p = 0,012). Die Aufenthaltsdauer war zwischen allen Quartalen 2020 im Vergleich zum Kontrollzeitraum numerisch, aber nicht signifikant unterschiedlich. Schlussfolgerung Die COVID-19-Pandemie zeigt deutliche Auswirkungen auf die stationäre psychiatrische Versorgung. Zukünftig muss der Blick stärker auf die Notfall- und Krisenversorgung psychisch erkrankter Menschen gelenkt werden.

Zusammenfassung Hintergrund ERAS (Enhanced Recovery After Surgery) beschreibt ein multimodales, interdisziplinäres und interprofessionelles Behandlungskonzept, welches die postoperative Rekonvaleszenz des Patienten durch den Einsatz evidenzbasierter Maßnahmen optimiert. Ziel der Arbeit (Fragestellung) Ziel dieses Artikels ist es, die ökonomische Abbildbarkeit des Konzeptes im deutschen DRG-System zu untersuchen. Material und Methoden Seit August 2019 werden Patienten in unserer Klinik nach dem später zertifizierten ERAS-Konzept behandelt. Die letzten 20 Patienten vor ERAS-Implementierung werden im Folgenden mit 20 Patienten nach ERAS-Implementierung verglichen, die über eine Matched-Pair-Analyse identifiziert wurden. Neben dem Vergleich von Kosten und Erlös wird auch das klinische Outcome der Patienten dargestellt. Ergebnisse Die Fälle der Patienten der präERAS-Kohorte haben mediane Kosten von 7432,83 € verursacht. Abrechenbar waren BWR von 3,38. Der daraus resultierende DRG-Erlös für die Patienten dieser Gruppe belief sich auf 11325,78 €. Der letztlich generierte Erlös belief sich somit auf 4575,14 €. Die Fälle der Patienten der ERAS-Kohorte haben Kosten von 5582,96 € verursacht. Abrechenbar waren BWR in Höhe von 2,84. Der DRG-Erlös für die Patienten dieser Gruppe belief sich demnach auf 10014,18 €. Der erwirtschaftete Gewinn betrug somit 4993,84 €. Diskussion Die durch ERAS generierte Kostenreduktion war vergleichbar zum „Verlust“ durch den BWR-Rückgang. ERAS ist demnach auch im deutschen DRG-System kostendeckend möglich.

PURPOSE:The Mid-German Sepsis Cohort (MSC) aims to investigate mid-term and long-term functional disabilities in sepsis survivors from intensive care unit (ICU) discharge until 1 year after. Secondary, post-acute mortality and morbidity, health-related quality of life and healthcare utilisation will be investigated.PARTICIPANTS:The MSC comprises adult (aged ≥18 years) patients who were treated for (severe) sepsis or septic shock on ICU. The participants were recruited between 15 April 2016 and 30 November 2018 from five German centres. Three thousand two hundred and ten patients with sepsis were identified, of which 1968 survived their ICU stay and were eligible for enrolment in the follow-up cohort. Informed consent for follow-up assessment was provided by 907 patients (46.1% of eligible patients).FINDINGS TO DATE:The recruitment of the participants for follow-up assessments and the baseline data collection is completed. Incidence of sepsis was 116.7 patients per 1000 ICU patients. In this cohort profile, we provide an overview of the demographics and the clinical characteristics of both the overall sepsis cohort and the ICU survivors who provided informed consent for follow-up assessment (907 out of 1968 ICU survivors (46.1%)).FUTURE PLANS:The follow-ups are conducted 3, 6 and 12 months after ICU discharge. Another yearly follow-up up to 5 years after ICU discharge is pursued. Several cooperation and satellite projects were initiated. This prospective cohort offers a unique resource for research on long-term sequelae of sepsis survivors.TRIAL REGISTRATION NUMBER:German Clinical Trials Registry (DRKS00010050).

Abstract Introduction Several reports indicate lower rates of emergency admissions in the cardiovascular sector and reduced admissions of patients with chronic diseases during the COVID-19 pandemic. The aim of this study was therefore to evaluate numbers of admissions in incident and prevalent atrial fibrillation and flutter (AF) and to analyze care pathways in comparison to 2019. Methods A retrospective analysis of claims data of 74 German Helios hospitals was performed to identify consecutive patients hospitalized with a main discharge diagnosis of AF. A study period including the start of the German national protection phase (13th March 2020 to 16th July 2020) was compared to a previous year control cohort (15th March 2019 to 18th July 2019), with further sub-division into early and late phase. Incidence rate ratios (IRR) were calculated. Numbers of admission per day (A/day) for incident and prevalent AF and care pathways including readmissions, numbers of transesophageal echocardiogram (TEE), electrical cardioversion (CV) and catheter ablation (CA) were analyzed. Results During the COVID-19 pandemic, there was a significant decrease of total AF admissions both in the early (44.4 vs. 77.5 A/day, IRR 0.57 [95% CI 0.54–0.61], p < 0.01) and late phase (59.1 vs. 63.5 A/day, IRR 0.93 [95% CI 0.90–0.96], p < 0.01), length of stay was significantly shorter (3.3 ± 3.1 nigths vs. 3.5 ± 3.6 nigths, p < 0.01), admissions were more frequently in high volume centers (77.0% vs. 75.4%, p = 0.02) and frequency of readmissions was reduced (21.7% vs. 23.6%, p < 0.01) compared to the previous year. Incident AF admission rates were significantly lower both in the early (21.9 admission per day vs. 41.1 A/day, IRR 0.53 [95% CI 0.48 − 0.58]) and late phase (35.5 vs. 39.3 A/day, IRR 0.90 [95% CI 0.86 − 0.95]), whereas prevalent admissions were only lower in the early phase (22.5 vs 36.4 A/day IRR 0.62 [95% CI 0.56 − 0.68]), but not in the late phase (23.6 vs. 24.2 A/day IRR 0.97 [95% CI 0.92 − 1.03]). Analysis of care pathways showed reduced numbers of TEE during the early phase (34.7% vs. 41.4%, OR 0.74 [95% CI 0.64 − 0.86], p < 0.01), but not during the late phase (39.9% vs. 40.2%, OR 0.96 [95% CI 0.88 − 1.03], p = 0.26). Numbers of CV were comparable during early (40.6% vs. 39.7%, OR 1.08 [95% CI 0.94 − 1.25], p = 0.27) and late phase (38.6% vs. 37.5%, OR 1.06 [95% CI 0.98 − 1.14], p = 0.17), compared to the previous year, respectively. Numbers of CA were comparable during the early phase (21.6% vs. 21.1%, OR 0.98 [95% CI 0.82 − 1.17], p = 0.82) with a distinct increase during the late phase (22.9% vs. 21.5%, OR 1.05 [95% CI 0.96–1.16], p = 0.28). Conclusion During the COVID-19 pandemic, AF admission rates declined significantly, with a more pronounced reduction in incident than in prevalent AF. Overall AF care was maintained during early and late pandemic phase with only minor changes, namely less frequent use of TEE. Confirmation of these findings in other study populations as well as identification of underlying causes are required to ensure optimal therapy in patients with AF during the COVID-19 pandemic.

COVID-19 has led to profound changes in the world as we have known it. Due to the sharp increase in intensive care, COVID patients, elective admissions and interventions have been postponed. But emergencies such as myocardial infarction have also decreased. The present study deals with the effects of the COVID pandemic on visceral surgical emergencies on the basis of 5 indicator operations. Routine data from 73 acute hospitals of the Helios Group were evaluated for this purpose. The interventions that were carried out between March 13, 2020 and March 12, 2021 were included. The data was compared with the period from March 13, 2019 to March 12, 2020. The number of interventions in serious emergencies (ileus, mesenteric ischemia and ulcer perforation) has remained constant. However, the length of stay in hospital in the pandemic year 2020 was significantly shorter than in the reference year 2019. The number of cholecystectomies and appendectomies in the pandemic year was significantly lower than in the reference year 2019. The outcome parameters intensive care, invasive ventilation and hospital mortality were comparable for the two periods for these interventions.

Background: After the first COVID-19 infection wave, a constant increase of pulmonary embolism (PE) hospitalizations not linked with active PCR-confirmed COVID-19 was observed, but potential contributors to this observation are unclear. Therefore, we analyzed associations between changes in PE hospitalizations and (1) the incidence of non-COVID-19 pneumonia, (2) the use of computed tomography pulmonary angiography (CTPA), (3) volume depletion, and (4) preceding COVID-19 infection numbers in Germany. Methods: Claims data of Helios hospitals in Germany were used, and consecutive cases with a hospital admission between May 6 and December 15, 2020 (PE surplus period), were analyzed and compared to corresponding periods covering the same weeks in 2016–2019 (control period). We analyzed the number of PE cases in the target period with multivariable Poisson general linear mixed models (GLMM) including (a) cohorts of 2020 versus 2016–2019, (b) the number of cases with pneumonia, (c) CTPA, and (d) volume depletion and adjusted for age and sex. In order to associate the daily number of PE cases in 2020 with the number of preceding SARS-CoV-2 infections in Germany, we calculated the average number of daily infections (divided by 10,000) occurring between 14 up to 90 days with increasing window sizes before PE cases and modeled the data with Poisson regression. Results: There were 2,404 PE hospitalizations between May 6 and December 15, 2020, as opposed to 2,112–2,236 (total 8,717) in the corresponding 2016–2019 control periods (crude rate ratio [CRR] 1.10, 95% CI 1.05–1.15, P < 0.01). With the use of multivariable Poisson GLMM adjusted for age, sex, and volume depletion, PE cases were significantly associated with the number of cases with pneumonia (CRR 1.09, 95% CI 1.07–1.10, P < 0.01) and with CTPA (CRR 1.10, 95% CI 1.09–1.10, P < 0.01). The increase of PE cases in 2020 compared with the control period remained significant (CRR 1.07, 95% CI 1.02–1.12, P < 0.01) when controlling for those factors. In the 2020 cohort, the number of preceding average daily COVID-19 infections was associated with increased PE case incidence in all investigated windows, i.e., including preceding infections from 14 to 90 days. The best model (log likelihood −576) was with a window size of 4 days, i.e., average COVID-19 infections 14–17 days before PE hospitalization had a risk of 1.20 (95% CI 1.12–1.29, P < 0.01). Conclusions: There is an increase in PE cases since early May 2020 compared to corresponding periods in 2016–2019. This surplus was significant even when controlling for changes in potential modulators such as demographics, volume depletion, non-COVID-19 pneumonia, CTPA use, and preceding COVID-19 infections. Future studies are needed (1) to investigate a potential causal link for increased risk of delayed PE with preceding SARS-CoV-2 infection and (2) to define optimal screening for SARS-CoV-2 in patients presenting with pneumonia and PE.

Sepsis is an acute life-threatening organ dysfunction resulting from an inadequate host response to an infection. The diagnosis of sepsis-associated organ dysfunction should be based on a change of >= 2 points using the Sequential Organ Failure Assessment (SOFA) score. An intravenous crystalloid solution should be administered within the first 3 hours to achieve a haemodynamic stabilisation of the patient. A 0.9% NaCl solution should NOT be used. A schematic minimum infusion amount and a general target value for the mean arterial blood pressure are not recommended. Intravenous anti-infectives should be administered as soon as possible if possible within 1 hour after confirmed diagnosis. The application of an empirical broad-spectrum antibiotic or multiple antibiotics is recommended in order to account for all significant bacteria. Measurements of the procalcitonin value should be done to shorten the duration of antimicrobial therapy.

Background Pseudomonas aeruginosa infections are a serious threat in intensive care units (ICUs). The aim of this confirmatory, randomized, multicenter, placebo-controlled, double-blind, phase 2/3 study was to assess the efficacy, immunogenicity, and safety of IC43 recombinant Pseudomonas aeruginosa vaccine in non-surgical ICU patients. Methods Eight hundred patients aged 18 to 80 years admitted to the ICU with expected need for mechanical ventilation for ≥ 48 h were randomized 1:1 to either IC43 100 μg or saline placebo, given in two vaccinations 7 days apart. The primary efficacy endpoint was all-cause mortality in patients 28 days after the first vaccination. Immunogenicity and safety were also evaluated. Findings All-cause mortality rates at day 28 were 29.2% vs 27.7% in the IC43 and placebo groups, respectively ( P = .67). Overall survival (Kaplan-Meier survival estimates, P = .46) and proportion of patients with ≥ one confirmed P. aeruginosa invasive infection or respiratory tract infection also did not differ significantly between both groups. The geometric mean fold increase in OprF/I titers was 1.5 after the first vaccination, 20 at day 28, after the second vaccination, and 2.9 at day 180. Significantly more patients in the placebo group (96.5%) had ≥ one adverse event (AE) versus the IC43 100 μg group (93.1%) ( P = .04). The most frequently reported severe AEs in the IC43 and placebo groups were respiratory failure (6.9% vs 5.7%, respectively), septic shock (4.1% vs 6.5%), cardiac arrest (4.3% vs 5.7%), multiorgan failure (4.6% vs 5.5%), and sepsis (4.6% vs 4.2%). No related serious AEs were reported in the IC43 group. Interpretation The IC43 100 μg vaccine was well tolerated in this large population of medically ill, mechanically ventilated patients. The vaccine achieved high immunogenicity but provided no clinical benefit over placebo in terms of overall mortality. Trial registration https://clinicaltrials.gov ( NCT01563263 ). Registration was sent to ClinicalTrials.gov on March 14, 2012, but posted by ClinicalTrials.gov on March 26, 2012. The first subject was included in the trial on March 22, 2012.

BACKGROUND: Sepsis survivors face mental and physical sequelae even years after discharge from the intensive care unit. The aim of this study was to evaluate the long-term courses of sepsis survivors and the effects of a primary care management intervention in sepsis aftercare. METHODS: This study presents a 24-month follow-up of a randomized controlled trial that recruited 291 patients who survived sepsis (including septic shock) from nine German intensive care units. Participants were randomized to usual care (n=143) or to a 12-month-intervention (n=148). The intervention included training of patients and their primary care physicians (PCP) in evidence-based post-sepsis care, case management provided by trained nurses, and clinical decision support for PCPs by consulting physicians. Usual care was provided by PCPs in the control group. RESULTS: One hundred eighty-six (63.9%, 98 intervention, 88 control) of 291 patients completed the 24-month follow-up, showing both increased mortality and recovery from functional impairment. Unlike the intervention group, the control group showed a significant increase of posttraumatic stress symptoms according to the Posttraumatic Symptom Scale (difference between baseline and 24-months follow-up values, mean [standard deviation] 3.7 [11.8] control vs -0.7 [12.1] intervention; P = .016). There were no significant differences in all other outcomes between the intervention and control groups. CONCLUSIONS: Twelve months after completion, a primary care management intervention among survivors of sepsis did not improve mental health-related quality of life. Patients in the intervention group showed less posttraumatic stress symptoms. (C) 2019 Elsevier Inc. All rights reserved.

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2020 F. M. Brunkhorst · M. A. Weigand · M. Pletz · P. Gastmeier · S. W. Lemmen · A. Meier-Hellmann · M. Ragaller · A. Weyland · G. Marx · M. Bucher · H. Gerlach · B. Salzberger · B. Grabein · T. Welte · K. Werdan · S. Kluge · H. G. Bone · C. Putensen · R. Rossaint · M. Quintel · C. Spies · B. Weiß · S. John · M. Oppert · A. Jörres · T. Brenner · G. Elke · M. Gründling · K. Mayer · A. Weimann · T. W. Felbinger · H. Axer · Deutsche Sepsis Gesellschaft e.V. 1 Zentrum für Klinische Studien, Integriertes Forschungsund Behandlungszentrum (IFB) Sepsis und Sepsisfolgen, Klinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Jena, Jena, Deutschland; 2 Klinik für Anästhesiologie, UniversitätsklinikumHeidelberg, Heidelberg, Deutschland; 3 Institut für Infektionsmedizin und Krankenhaushygiene, Universitätsklinikum Jena, Jena, Deutschland; 4 Institut für Hygiene und Umweltmedizin, Charité – Universitätsmedizin Berlin, Berlin, Deutschland; 5 Zentralbereich für Krankenhaushygiene und Infektiologie, UniversitätsklinikumAachen, Aachen, Deutschland; 6 Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, Helios Klinikum Erfurt GmbH, Erfurt, Deutschland; 7 Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Dresden, Dresden, Deutschland; 8 Klinik für Anästhesiologie, Intensivmedizin, Notfallmedizin, Schmerztherapie, KlinikumOldenburg gGmbH, Oldenburg, Deutschland; 9 Klinik für Operative Intensivmedizin und Intermediate Care, UniversitätsklinikumAachen, Aachen, Deutschland; 10 Klinik für Anästhesiologie und Operative Intensivmedizin, UniversitätsklinikumHalle, Halle, Deutschland; 11 Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Vivantes KlinikumNeukölln, Berlin, Deutschland; 12 Abteilung für Krankenhaushygiene und Infektiologie, UniversitätsklinikumRegensburg, Regensburg, Deutschland; 13 Stabsstelle Klinische Mikrobiologie und Krankenhaushygiene, Klinikum der Universität München, München, Deutschland; 14 Klinik für Pneumologie, Medizinische Hochschule Hannover, Hannover, Deutschland; 15 Universitätsklinik und Poliklinik für Innere Medizin III., Klinikum der MLU Halle-Wittenberg,Halle, Deutschland; 16 Klinik für Intensivmedizin, UniversitätsklinikumHamburgEppendorf, Hamburg, Deutschland; 17 Zentrum für Anästhesiologie, Intensivmedizin und Schmerztherapie, Knappschaftskrankenhaus Recklinghausen, Recklinghausen, Deutschland; 18 Klinik für Anästhesiologie und Operative Intensivmedizin, UniversitätsklinikumBonn, Bonn, Deutschland; 19 Klinik für Anästhesiologie, UniversitätsklinikumAachen, Aachen, Deutschland; 20 Klinik für Anästhesiologie, Universitätsmedizin Göttingen, Göttingen, Deutschland; 21 Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Charité – Universitätsmedizin Berlin, Berlin, Deutschland; 22 Klinik für Innere Medizin 8, Schwerpunkt Kardiologie, KlinikumNürnberg, Nürnberg, Deutschland; 23 Klinik für Notfallund Internistische Intensivmedizin, Klinikum Ernst von Bergmann Potsdam, Potsdam, Deutschland; 24 Klinik für Nephrologie, Transplantationsmedizin und internistische Intensivmedizin, Medizinische Klinik I Krankenhaus Merheim, Klinikum der Universität Witten/Herdecke, Köln, Deutschland; 25 Klinik für Anästhesiologie und Operative Intensivmedizin, UniversitätsklinikumKiel, Kiel, Deutschland; 26 Klinik für Anästhesiologie – Anästhesie, Intensiv-, Notfallund Schmerzmedizin, UniversitätsklinikumGreifswald, Greifswald, Deutschland; Medizinische Klinik und Poliklinik II, Klinikum der Justus-Liebig-Universität Gießen, Gießen, Deutschland; 28 Klinik für Allgemein-, Viszeralund Onkologische Chirurgie, Klinikum „St. Georg“ Leipzig gGmbH, Leipzig, Deutschland; 29 Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie, Städtisches KlinikumMünchen, München, Deutschland; 30 Klinik für Neurologie, Universitätsklinikum Jena, Jena, Deutschland; 31 Universitätsklinikum Jena, Jena, Deutschland

The aim of this clinical registry is to record the use of CytoSorb® adsorber device in critically ill patients under real-life conditions.

Guidelines recommend administering antibiotics within 1 h of sepsis recognition but this recommendation remains untested by randomized trials. This trial was set up to investigate whether survival is improved by reducing the time before initiation of antimicrobial therapy by means of a multifaceted intervention in compliance with guideline recommendations.

Objective We report on the effect of hemoadsorption therapy to reduce cytokines in septic patients with respiratory failure. Methods This was a randomized, controlled, open-label, multicenter trial. Mechanically ventilated patients with severe sepsis or septic shock and acute lung injury or acute respiratory distress syndrome were eligible for study inclusion. Patients were randomly assigned to either therapy with CytoSorb hemoperfusion for 6 hours per day for up to 7 consecutive days (treatment), or no hemoperfusion (control). Primary outcome was change in normalized IL-6-serum concentrations during study day 1 and 7. Results 97 of the 100 randomized patients were analyzed. We were not able to detect differences in systemic plasma IL-6 levels between the two groups (n = 75; p = 0.15). Significant IL-6 elimination, averaging between 5 and 18% per blood pass throughout the entire treatment period was recorded. In the unadjusted analysis, 60-day-mortality was significantly higher in the treatment group (44.7%) compared to the control group (26.0%; p = 0.039). The proportion of patients receiving renal replacement therapy at the time of enrollment was higher in the treatment group (31.9%) when compared to the control group (16.3%). After adjustment for patient morbidity and baseline imbalances, no association of hemoperfusion with mortality was found (p = 0.19). Conclusions In this patient population with predominantly septic shock and multiple organ failure, hemoadsorption removed IL-6 but this did not lead to lower plasma IL-6-levels. We did not detect statistically significant differences in the secondary outcomes multiple organ dysfunction score, ventilation time and time course of oxygenation.