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

ABSTRACT:

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-caus

SUBMITTER: Jiang W 

PROVIDER: S-EPMC5822617 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature