BackgroundHybrid clinical trial design integrates traditional randomized controlled trials (RCTs) with real-world data (RWD), aiming to enhance trial efficiency through dynamic incorporation of external data (External trial data and RWD). However, existing methods, such as the Meta-Analytic Predictive (MAP) Prior, exhibit serious limitations in controlling data heterogeneity, adjusting baseline discrepancies, and optimizing dynamic borrowing proportions. These limitations often introduce external bias or compromise evidence reliability, hindering their application in complex analyses like bridging trials and multi-regional clinical trials (MRCTs).ObjectiveThis study proposes a novel hybrid Bayesian framework, EQPS Robust MAP (rMAP), to address heterogeneity and bias in multi-source data integration. Its feasibility and robustness are validated through systematic simulations and retrospective case analyses, using two independent datasets to evaluate the effect of Risankizumab in patients with moderate-to-severe plaque psoriasis.Design and MethodsThe EQPS-rMAP method operates in three stages: (1) Eliminating baseline covariate discrepancies through propensity score stratification; (2) constructing stratum-specific MAP priors to dynamically adjust weights for external data; and (3) introducing equivalence probability weights to quantify data conflict risks. The study evaluates the method's performance across six simulated analyses (heterogeneity differences, baseline shifts, etc.), comparing it with traditional methods (MAP, PSMAP, Empirical Bayes MAP) in terms of estimation bias, type I error control, and sample size requirements. Real-world case analyses further validate its applicability.ResultsSimulations demonstrate that EQPS-rMAP maintains estimation robustness under considerable heterogeneity while reducing sample size demands and enhancing trial efficiency. Case analyses confirm its ability to control external bias while preserving high estimation accuracy compared to conventional approaches.ConclusionThe EQPS-rMAP method provides empirical evidence for the feasibility of hybrid clinical designs. Its methodological advancements-resolving baseline and heterogeneity conflicts through adaptive mechanisms-offer broader applicability for integrating external and RWD across diverse analyses, including bridging trials, MRCTs, and post-marketing studies.

The transformation of China's healthcare system is increasingly driven by the development of real-world data (RWD) and real-world evidence (RWE). In the context of the "Healthy China 2030" initiative, which emphasizes addressing the growing burden of non-communicable diseases (NCDs), this article assesses the current state and potential of RWD/RWE development. Key areas of focus include the policy environment, guideline systems, data foundations and tools, and talent development. The article outlines a comprehensive roadmap for advancing high-quality RWD/RWE in China, emphasizing the construction of nationwide RWD sources and the harmonization of patient-centered RWD public-private partnerships. As a call to action, the article proposes specific recommendations for various healthcare stakeholders (government, regulatory authorities, industry, academia, clinical researchers and institutions, and data service providers) to collaboratively establish a robust and sustainable RWE ecosystem in China. By leveraging these efforts, the ultimate goal is to significantly improve healthcare outcomes, enhance the efficiency of healthcare delivery, and support evidence-based policymaking, thereby contributing to the overall health and wellbeing of the population.

Background:The presence of delayed treatment effects(DTE)is common in immuno-oncology trials.However,conventional trial designs often overlook the potential presence of DTE,which can result in an underestimation of the required sample size and loss of statistical power.Conversely,when there is actually no apparent delay in treatment effects,alternative trial designs for addressing DTE may lead to an over-estimation of sample size and unnecessary prolongation of the trial duration.To mitigate this challenge,we propose the use of a DTE predicting(DTEP)model to better guide immuno-oncology trial designs. Methods:The DTEP model was developed and validated using data from 147 pub-lished randomized immuno-oncology trials.The eligible trials were divided into a training set(approximately 75％of the trials)and a test set(approximately 25％).We employed linear discriminant analysis(LDA)to develop the DTEP model for pre-dicting the DTE status using baseline characteristics available at the trial design stage.The receiver operating characteristic(ROC)curve was utilized to assess the ability of the model to distinguish between trials with and without DTE.We further re-conducted the JUPITER-02 trial in a simulation setting,employing three design approaches to assess the potential benefits of utilizing the DTEP model. Results:Baseline characteristics available during the trial design stage,including cancer type,line of treatment,and experimental and control arm regimens were incorporated,and high accuracy in predicting the DTE status in both the training set(area under the operating characteristic curve(AUC),0.79;95％confidence interval(CI),0.71-0.88)and test set(AUC,0.78;95％CI,0.66-0.90)was achieved.Notably,the model successfully predicted the DTE status in two randomized trials among the test sets that were conducted by our team(ESCORT-1st(absence of DTE)and JUPITER-02(presence of DTE)).In silico re-conduct of the JUPITER-02 trial further showed that the statistical power would be markedly improved when trial designs were guided by the DTEP model. Conclusions:The DTEP model can significantly enhance the precision and effectiveness of immuno-oncology trial designs,thereby facilitating the discovery of effective im-munotherapeutics in a more streamlined and expedited manner.

External data (e.g., real-world data (RWD) and historical data) have become more readily available. This has led to rapidly increasing interest in exploring and evaluating ways of utilizing external data to facilitate traditional clinical trials (TCT), especially for rare diseases with high unmet medical needs where a TCT would be impractical and/or unethical. In this article, we focus on hybrid studies that incorporate external data into randomized clinical trials to augment the control arm and explore a complex innovative design. A sequential adaptive design conducts multiple interim assessments to improve the accuracy of estimates of agreement between external data and current data. At each interim assessment, we apply the inverse probability weighted power prior (IPW-PP) method to adaptively borrow information from external data to account for confounding and heterogeneity. The randomization ratio is dynamically adjusted during the interim assessment based on accumulatively augmented information to reduce the sample size of the current trial. Additionally, the proposed design can be extended to allow interim analyses for early efficacy/futility stopping, that is, early assessment of trial success or failure based on accumulated data, potentially reducing ineffective treatment exposure and unnecessary time and resources. The performance of the proposed method and design is evaluated via extensive simulation studies. The sequential adaptive design and IPW-PP approach having desirable properties are implemented.

Background Although it has been established that elevated blood pressure and its variability worsen outcomes in spontaneous intracerebral hemorrhage, antihypertensives use during the acute phase still lacks robust evidence. A blood pressure–lowering regimen using remifentanil and dexmedetomidine might be a reasonable therapeutic option given their analgesic and antisympathetic effects. The objective of this superiority trial was to validate the efficacy and safety of this blood pressure–lowering strategy that uses remifentanil and dexmedetomidine in patients with acute intracerebral hemorrhage. Methods In this multicenter, prospective, single-blinded, superiority randomized controlled trial, patients with intracerebral hemorrhage and systolic blood pressure (SBP) 150 mmHg or greater were randomly allocated to the intervention group (a preset protocol with a standard guideline management using remifentanil and dexmedetomidine) or the control group (standard guideline-based management) to receive blood pressure–lowering treatment. The primary outcome was the SBP control rate (less than 140 mmHg) at 1 h posttreatment initiation. Secondary outcomes included blood pressure variability, neurologic function, and clinical outcomes. Results A total of 338 patients were allocated to the intervention (n = 167) or control group (n = 171). The SBP control rate at 1 h posttreatment initiation in the intervention group was higher than that in controls (101 of 161, 62.7% vs. 66 of 166, 39.8%; difference, 23.2%; 95% CI, 12.4 to 34.1%; P < 0.001). Analysis of secondary outcomes indicated that patients in the intervention group could effectively reduce agitation while achieving lighter sedation, but no improvement in clinical outcomes was observed. Regarding safety, the incidence of bradycardia and respiratory depression was higher in the intervention group. Conclusions Among intracerebral hemorrhage patients with a SBP 150 mmHg or greater, a preset protocol using a remifentanil and dexmedetomidine–based standard guideline management significantly increased the SBP control rate at 1 h posttreatment compared with the standard guideline-based management. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Objective To evaluate the clinical efficacy and safety of Huzhen Qingfeng Capsule（HZQFC） in the treatment of acute gouty arthritis patients with damp-heat accumulation syndrome（DHAS）.Methods A randomized, double-blind, placebo-controlled, multicenter, superiority testing clinical trial was performed. A total of 480 acute gouty arthritis patients with DHAS were collected from 14 hospitals across China.They were randomly assigned to the treatment group（360 cases） and the control group（120 cases） using SAS Software at 3 :1 by stratified block randomization. Patients in the treatment group took HZQFC, while those in the control group took HZQFC simulators. All patients took 4 capsules each time, 3 times a day, for a total of 3days. The visual analogue scale（VAS） of pain, TCM syndrome score, the disappearance rate of each symptom, erythrocyte sedimentation rate（ESR）, C-reactive protein（CRP）, blood routines（white blood cell count）, and the incidence of adverse events were observed before and after treatment. Results Of 480 subjects, 438were included in the full analysis set（FAS） for efficacy analysis. There were 325 cases in the treatment group with 35 cases dropped off（including 2 cases with adverse events, 29 lost to follow-ups, 2 cases violating the protocols, and 2 cases withdrawn from the trial due to lack of efficacy）. There were 113 cases in the control group with 7 cases dropped off（including 2 cases lost to follow-ups and 5 cases violating the protocols）. The VAS score and difference of pain in the treatment group on the third day were better than those in the control group, and the differences were statistically significant（t =7.241, t =6.452, P＜0.01）. The total effective rate of TCM syndrome in the treatment group was 91.4%（297/325）, better than that [68.1%（77/113）] in the control group with statistical difference（χ~2=7.184, P＜0.01）. The TCM syndrome scores and differences of the treatment group on the third day were better than those of the control group, and the differences were statistically significant（t =7.126, t =6.417, P＜0.01）. In terms of the disappearance rate of 9 individual symptoms, including joint pain, joint swelling, joint fever, joint skin color, mobility inconvenience, joint tenderness, fever, thirst, restlessness, the disappearance rate of the treatment group was higher than that of the control group except fever（P＜0.01）.After 3 days of treatment there were no significant differences in ESR, CRP, or WBC count between the two groups（P＞0.05）. The incidence of adverse events during the treatment was 24.4%（87/357） in the treatment group and 24.8%（30/121） in the control group, and the difference was not significant（χ~2=0.009,P＞0.05）.Conclusions HZQFC effectively relieved joint pain of acute gouty arthritis patients with DHAS, with shorter onset time. But its safety was comparable to placebos. So the clinical application was safe.

BACKGROUND:Patients with chronic kidney disease (CKD) undergoing coronary angiography (CAG) are at high risk of contrast-associated acute kidney injury (CA-AKI) and mortality. Therefore, there is a clinical need to explore safe, convenient, and effective strategies for preventing CA-AKI. OBJECTIVES:This study sought to assess whether simplified rapid hydration is noninferior to standard hydration for CA-AKI prevention in patients with CKD. METHODS:This multicenter, open-label, randomized controlled study was conducted across 21 teaching hospitals and included 1,002 patients with CKD. Patients were randomized to either simplified hydration (SH) (SH group, with normal saline from 1 hour before to 4 hours after CAG at a rate of 3 mL/kg/h) or standard hydration (control group, with normal saline 12 hours before and 12 hours after CAG at a rate of 1 mL/kg/h). The primary endpoint of CA-AKI was a ≥25% or 0.5-mg/dL rise in serum creatinine from baseline within 48 to 72 hours. RESULTS:CA-AKI occurred in 29 of 466 (6.2%) patients in the SH group and in 38 of 455 (8.4%) patients in the control group (relative risk: 0.8; 95% CI: 0.5-1.2; P = 0.216). In addition, the risk of acute heart failure and 1-year major adverse cardiovascular events did not differ significantly between the groups. However, the median hydration duration was significantly shorter in the SH group than in the control group (6 vs 25 hours; P < 0.001). CONCLUSIONS:In CKD patients undergoing CAG, SH is noninferior to standard hydration in preventing CA-AKI with a shorter hydration duration.

Background The appropriate administration regimen of polymyxin B is yet controversial. The present study aimed to explore the optimal dose of polymyxin B under therapeutic drug monitoring (TDM) guidance. Methods In China’s Henan province, 26 hospitals participated in a randomized controlled trial. We included patients with sepsis caused by carbapenem-resistant Gram-negative bacteria (CR-GNB) susceptible to polymyxin B. The patients were randomly divided into a high-dose (HD) group or a low-dose (LD) group and received 150 mg loading dose, 75 mg every 12 h and 100 mg loading dose, 50 mg every 12 h, respectively. TDM was employed to determine if the dose of polymyxin B needs adjustment based on the area under the concentration–time curve across 24 h at a steady state (ssAUC 0–24 ) of 50–100 mg h/L. The primary outcome was the 14-day clinical response, and the secondary outcomes included 28- and 14-day mortality. Results This trial included 311 patients, with 152 assigned to the HD group and 159 assigned to the LD group. Intention-to-treat analysis showed that the 14-day clinical response was non-significant ( p = 0.527): 95/152 (62.5%) in the HD group and 95/159 (59.7%) in the LD group. Kaplan–Meier’s 180-day survival curve showed survival advantage in the HD group than in the LD group ( p = 0.037). More patients achieved the target ssAUC 0–24 in the HD than in the LD group (63.8% vs. 38.9%; p = 0.005) and in the septic shock subgroup compared to all subjects (HD group: 71.4% vs. 63.8%, p = 0.037; LD group: 58.3% vs. 38.9%, p = 0.0005). Also, the target AUC compliance was not correlated with clinical outcomes but with acute kidney injury (AKI) ( p = 0.019). Adverse events did not differ between the HD and LD groups. Conclusion A fixed polymyxin B loading dose of 150 mg and a maintenance dose of 75 mg every 12 h was safe for patients with sepsis caused by CR-GNB and improves long-term survival. The increased AUC was associated with increased incidence of AKI, and TDM results were valued to prevent AKI. Trial registration Trial registration ClinicalTrials.gov: ChiCTR2100043208, Registration date: January 26, 2021.

Surgical resection is cornerstone treatment for early-stage non-small cell lung cancer (NSCLC) and offers a chance for cure. This study was conducted to determine current surgical treatment patterns and outcomes of Chinese patients with NSCLC. Data of patients with histologically confirmed NSCLC of stages IA–IIIA and who underwent surgery between July 2014 and July 2020 were retrospectively collected from 9 tertiary hospitals in China. Cox model was used for multivariate analyses. This study included 11,958 patients, among whom 59.1

In this paper, a univariate finite mixed generalized normal distribution (MixGND) is proposed. First, we derive some probabilistic properties including hazard rate function, characteristic function, kurtosis and skewness, for a mixture of two generalized normal distributions. In particular, we use a geometric analysis and numerical simulation technique to study the monotonicity of skewness and kurtosis from prescribing corresponding parameters. Then moment estimation and maximum likelihood estimation of parameters are also given. To use the maximum likelihood estimation (MLE) method, an expectation conditional maximization (ECM) algorithm is proposed to estimate and numerically simulate seven parameters of a two-component MixGND under the same variance and heteroscedasticity. By using data sets of the S&P 500 and Shanghai Stock Exchange Composite Index (SSEC), we compare goodness-of-fit performance between the mixture of two generalized normal distributions and the mixture of two normal distributions. The empirical analysis results show that the former better describes the heavy-tailed and leptokurtic characteristics of the daily returns.

Background Inadequate postoperative pain management increases the risk of adverse events after the surgery and aggressive perioperative pain prevention has both short-term and long-term benefits. S(+)-ketamine is an N-methyl-D-aspartic acid (NMDA) receptor antagonist with a strong analgesic effect and can significantly relieve postoperative acute pain and reduce opioid consumption. However, for children, it still needs to be confirmed by large sample clinical studies. Methods This is a pragmatic, randomized controlled trial which will evaluate the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children in a pragmatic clinical setting. A total of 3000 children (≤17 years old) undergoing surgery will be included in this protocol. Subjects will be randomized 2:1 to either receive S(+)-ketamine hydrochloride injection or conventional therapy without S(+)-ketamine during the entire perioperative period. The primary endpoints are the area under the receiver operating characteristic (ROC) curve of Face Legs Activity Cry and Consolability (FLACC, 0–7 years old) scale score or Numerical Rating Scale (NRS, 8–17 years old) score within 48 h after surgery, and the consumption of opioids within 48 h after surgery. The secondary endpoints include the time of first use of rescue analgesics after surgery, rescue analgesia rate within 48 h after surgery, anesthesia recovery time, incidence of emergency delirium (for 0-7 years old), changes of anxiety and depression scale scores at 48 h after surgery (for 8-17 years old), incidence of intraoperative adverse events (AEs), and incidence of postoperative AEs and pharmacoeconomic indicators. AEs and serious AEs were recorded to evaluate safety. Discussion This trial will be the first pragmatic clinical trial to prospectively assess the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children, which is of great significance to the continuous optimization of clinical anesthesia and analgesia programs for children. Trial registration This trial was registered in the U.S. National Institutes of Health ClinicalTrials.gov database ( http://clinicaltrials.gov ; Registration number: NCT04834427). Registered on 8 April 2021.

Purpose: The treatment of radiation-induced brain injury (RI) caused by radiation therapy for head and neck cancer is challenging. Antiangiogenic therapy is a promising treatment. Apatinib is an oral tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptor 2. We aimed to assess the efficacy and safety of apatinib in patients with RI. Methods and Materials: In this phase 2, open-label, single-arm, prospective study, we recruited patients aged 35 to 80 years with prior radiation therapy history for head and neck cancer who had newly diagnosed RI at the Sun Yat-sen Memorial Hospital, China. Apatinib was administered at a dosage of 250 mg once daily orally for 4 weeks. A Simon minimax 2-stage design was performed. The primary outcome was the proportion of patients with overall clinical efficacy, defined as a radiographic response of >= 25% reduction in baseline brain edema volume on magnetic resonance fluid attenuated inversion recovery images at week 4. Secondary end points were the overall improvement rate of brain necrosis, neurologic function, and safety. Results: We screened 37 patients, 36 of whom were enrolled between October 17, 2019, and August 3, 2020. At the cutoff date, 36 patients were assessed for efficacy and safety (19 were enrolled in stage 1 and 17 in stage 2). Of the 36 patients evaluated for overall clinical efficacy, 22 patients (61.1%; 95% CI, 43.5%-76.9%) achieved the primary end point at week 4. Among the 31 patients with brain necrosis lesions, 19 patients (61.3%; 95% CI, 42.2%-78.2%) showed improvement of brain necrosis. The most common grade 1 to 2 adverse events were hand-foot syndrome, fatigue, and hypertension There were no treatment-related grade 4 to 5 toxic effects. Conclusions: Oral apatinib shows promising efficacy and is well-tolerated in patients with RI. Further randomized controlled studies are warranted. (C) 2022 Elsevier Inc. All rights reserved.

2019年出台的《中共中央国务院关于促进中医药传承创新发展的意见》中首次提出加快构建中医药理论、人用经验和临床试验相结合的中药注册审评证据体系.中药复方制剂是中药新药开发的主要来源,其在开发前已经有了相当长时间的临床应用,积累了较丰富的人用经验,即真实世界数据.为了有效利用这些数据资源,促进中药新药的研发和转化,本研究着重探讨真实世界研究支持中药新药研发时的常见情形及关注点,为构建"三结合"的中药注册审评证据体系提供借鉴.

Importance It is not clear whether laparoscopic and open distal gastrectomy produce similar outcomes among patients with locally advanced gastric cancer. Data from a multicenter, randomized clinical trial (Chinese Laparoscopic Gastrointestinal Surgical Study [CLASS]-01) showed that laparoscopic distal gastrectomy did not result in inferior disease-free survival at 3 years compared with open distal gastrectomy. Objective To report 5-year overall survival data from the CLASS-01 trial of laparoscopic vs open distal gastrectomy among patients with locally advanced gastric cancer. Design, Setting, and Patients This was a noninferiority, open-label, randomized clinical trial conducted at 14 centers in China. A total of 1056 eligible patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 12, 2012, to December 3, 2014. Final follow-up was on December 31, 2019. Interventions Participants were randomized in a 1:1 ratio after stratification by site, age, cancer stage, and histologic features to undergo either laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy. Main Outcomes and Measures The 5-year overall survival rates were updated to compare laparoscopic distal gastrectomy with open distal gastrectomy. All analyses were performed on an intention-to-treat basis. In addition, per-protocol and as-treated analyses were performed for overall survival. Results Data from 1039 patients (726 men [69.9%]; mean [SD] age, 56.2 [10.7] years) who received curative therapy were analyzed. At 5 years, the overall survival rates were 72.6% in the laparoscopic distal gastrectomy group and 76.3% in the open distal gastrectomy group (log-rank P = .19; hazard ratio, 1.17; 95% CI, 0.93-1.48; P = .19). After comparison for competing risk events, gastric cancer-related deaths (hazard ratio, 1.14; 95% CI, 0.87-1.49; P = .34) and deaths from other causes (hazard ratio, 1.23; 95% CI, 0.74-2.05; P = .42) did not differ significantly between groups. Overall rates of survival did not differ significantly between groups with each tumor stage. Conclusions and Relevance This study found that laparoscopic distal gastrectomy with D2 lymphadenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar 5-year overall survival compared with open distal gastrectomy among patients with locally advanced gastric cancer. Trial Registration ClinicalTrials.gov Identifier: NCT01609309.

Noninferiority (NI) trial designs are often used to compare a new treatment with an active control for treating diseases for which use of a placebo control in a trial is ethically unacceptable. The validity of conclusion from an NI trial relies on some critical assumptions such as constancy assumption. This assumption, often unverifiable in a two-arm NI trial without a placebo control, refers to as the similarity of the active control effect in the current NI trial to that in the historical trials. Violation of the constancy assumption may lead to not only the inflation of Type I error, but also invalid conclusion of the NI trial. In this article, we propose a probabilistic bias analysis of historical data using the Bayesian hierarchical modeling framework to assess heterogeneity of active control effect and hence the constancy assumption. Both random sampling error and heterogeneity in the active control effect across historical trials will be accounted in the analysis of the current NI trial. The proposed method is illustrated using a real example of NI trial with a binary endpoint.

In phase II oncology trials, two-stage design allowing early stopping for futility and/or efficacy is frequently used. However, this design based on frequentist statistical approaches could not guarantee a high posterior probability of attending the pre-specified clinically interesting rate from a Bayesian perspective. Here, we proposed a new Bayesian design enabling early terminating for efficacy as well as futility. In addition to the clinically uninteresting and interesting response rate, a prior distribution of response rate, the minimum posterior threshold probabilities and the lengths of the highest posterior density intervals were specified in the design. Finally, we defined the feasible design with the highest total effective predictive probability. We studied the properties of the proposed design and applied it to an oncology trial as an example. The proposed design ensured that the observed response rate fell within prespecified levels of posterior probability. The proposed design provides an alternative design to single-arm two-stage trials.

ObjectiveTo evaluate the efficacy of aggressive hydration compared with general hydration for contrast-induced acute kidney injury (CI-AKI) prevention among patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).MethodsThe Aggressive hydraTion in patients with STEMI undergoing pPCI to prevenT Contrast-Induced Acute Kidney Injury study is an open-label, randomised controlled study at 15 teaching hospitals in China. A total of 560 adult patients were randomly assigned (1:1) to receive aggressive hydration or general hydration treatment. Aggressive hydration group received preprocedural loading dose of 125/250 mL normal saline within 30 min, followed by postprocedural hydration performed for 4 hours under left ventricular end-diastolic pressure guidance and additional hydration until 24 hours after pPCI. General hydration group received ≤500 mL 0.9% saline at 1 mL/kg/hour for 6 hours after randomisation. The primary end point is CI-AKI, defined as a >25% or 0.5 mg/dL increased in serum creatinine from baseline during the first 48–72 hours after primary angioplasty. The safety end point is acute heart failure.ResultsFrom July 2014 to May 2018, 469 patients were enrolled in the final analysis. CI-AKI occurred less frequently in aggressive hydration group than in general hydration group (21.8% vs 31.1%; risk ratio (RR) 0.70, 95% CI 0.52 to 0.96). Acute heart failure did not significantly differ between the aggressive hydration group and the general hydration group (8.1% vs 6.4%, RR 1.13, 95% CI 0.66 to 2.44). Several subgroup analysis showed the better effect of aggressive hydration in CI-AKI prevention in male, renal insufficient and non-anterior myocardial infarction participants.ConclusionsComparing with general hydration, the peri-operative aggressive hydration seems to be safe and effective in preventing CI-AKI among patients with STEMI undergoing pPCI.