Jiang Wei, Yu Xiangyou, Sun Tongwen, Chai Yanfen, Chang Ping, Chen Zhongqing, Pan Jingye, Peng Zhiyong, Wang Ruilan, Wang Xiaozhi, Xu Yuan, Yu Li, Zheng Qingshan, Du Bin
Medical Intensive Care Unit, Peking Union Medical College Hospital, 1 Shuai Fu Yuan, Beijing, 100730, China.
Department of Critical Care Medicine, Xinjiang Medical University 1st Hospital, Urumqi, Xinjiang, China.
Trials. 2018 Feb 21;19(1):133. doi: 10.1186/s13063-018-2513-y.
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.
METHODS/DESIGN: 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.
脓毒症是重症监护中的一项重大挑战，且与高死亡率相关。目前脓毒症和脓毒性休克的治疗仍主要是支持性治疗。基础研究和临床研究均表明，乌司他丁可改善脓毒症的预后。本试验的目的是评估乌司他丁与安慰剂相比的疗效和安全性。
方法/设计：在这项多中心、双盲、随机安慰剂对照试验中，我们将招募总共348名符合“脓毒症和脓毒性休克第三次国际共识定义”（Sepsis-3）的受试者。受试者将被随机分组（1:1），接受乌司他丁40万国际单位，每日三次，共10天，或同时接受匹配的安慰剂和常规治疗。主要结局是28天全因死亡率。将密切监测不良事件和严重不良事件。
ADJUST是在中国进行的一项关于乌司他丁的大型、多中心、双盲、随机、平行组、安慰剂对照试验，且在以往研究的基础上设计良好。本试验结果可能有助于为脓毒症治疗提供循证推荐。
ClinicalTrials.gov，标识符：NCT02647554。首次注册于2015年12月27日，最后一次验证于2016年12月。方案版本：2.1，于2016年7月19日验证。
