ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial

作者：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^*

来源：Trials, 2018, 19: 133.

DOI：10.1186/s13063-018-2513-y

• Ulinastatin
• Sepsis
• Septic shock
• Randomized controlled trial
• Mortality
• Safety

Background: 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.
Discussion: 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.

• 单位
  武汉大学; 上海中医药大学; 滨州医学院; 1; 清华大学; 武汉市中心医院; 郑州大学; 温州医学院; 上海交通大学; 中国医学科学院北京协和医院; 南方医科大学; 天津医科大学; 新疆医科大学; bpotest