机构：[1]Medical Intensive Care Unit, Peking Union Medical College Hospital, 1 Shuai Fu Yuan, Beijing 100730, China.[2]Department of Critical Care Medicine, Xinjiang Medical University 1st Hospital, Urumqi, Xinjiang, China.[3]Department of General Intensive Care Unit, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.[4]Department of Emergency, Tianjin Medical University General Hospital, Tianjin, China.[5]Department of Critical Care Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China.[6]Department of Critical Care Medicine, Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China.[7]Department of Critical Care Medicine, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.[8]Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.[9]Department of Critical Care Medicine, First People’s Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China.[10]Department of Critical Care Medicine, Binzhou Medical University Hospital, Binzhou, Shandong, China.[11]Department of Critical Care Medicine, Beijing Tsinghua Changgung Hospital Affiliated to Tsinghua University, Beijing, China.[12]Department of Critical Care Medicine, the Central Hospital of Wuhan Affiliated to Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, China.[13]Centre for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Sepsis is a major challenge in critical care and is associated with high mortality. Current management of sepsis and septic shock remains mainly supportive. Both basic and clinical research has shown that ulinastatin can improve the prognosis of sepsis. The aim of this trial is to evaluate the efficacy and safety profiles of ulinastatin compared with placebo.
In this multi-center, double-blind, randomized placebo-controlled trial we are recruiting a total of 348 subjects meeting "The Third International Consensus Definitions for Sepsis and Septic Shock" (Sepsis-3). Subjects will be randomized (1:1) to receive ulinastatin 400,000 IU three times a day for 10 days or matching placebo and usual care simultaneously. The primary outcome is 28-day all-cause mortality. Adverse events and serious adverse events will be monitored closely.
ADJUST is a large, multi-center, double-blind, randomized, parallel-group, placebo-controlled trial of ulinastatin in mainland China and is well-designed on the basis of previous studies. The results of this trial may help to provide evidence-based recommendations for treatment of sepsis.
ClinicalTrials.gov, ID: NCT02647554 . First registered on 27 December 2015, and last verified in December of 2016. Protocol version: 2.1, verified on 19 July 2016.
基金：
The ADJUST trial is supported by Guangdong Techpool Biopharmaceutical
Co, Ltd., which is also responsible for the supply of the study drug and
placebo as well as distribution to the participating centers. Funding agency
had no input into the design, conduct, data collection, statistical analysis, or
writing of the manuscript.
第一作者机构：[1]Medical Intensive Care Unit, Peking Union Medical College Hospital, 1 Shuai Fu Yuan, Beijing 100730, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Wei Jiang,Xiangyou Yu,Tongwen Sun,et al.ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial.[J].TRIALS.2018,19:doi:10.1186/s13063-018-2513-y.
APA：
Wei Jiang,Xiangyou Yu,Tongwen Sun,Yanfen Chai,Ping Chang...&China Critical Care Clinical Trials Group (CCCCTG).(2018).ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial..TRIALS,19,
MLA：
Wei Jiang,et al."ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial.".TRIALS 19.(2018)
