Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China

Summary

Participation Requirements

Description

Investigational drug?Ulinastain for Injection Study title? A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China Principal Investigator?Professor Bin Du, Medical Intensive Care Unit, Peking Un...

Investigational drug?Ulinastain for Injection Study title? A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China Principal Investigator?Professor Bin Du, Medical Intensive Care Unit, Peking Union Medical College Hospital; Professor Xiangyou Yu, Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University Study subjects? Adult patients with sepsis and septic shock will be eligible for inclusion if all of the inclusion criteria are met within 48 hours of meeting criteria of sepsis-3 definition Study phase? Investigator Initiated Trial(IIT) Study objectives? The primary objective of the study is to determine whether ulinastatin, compared to placebo, reduces 28-day all-cause mortality in patients with sepsis and septic shock Study design? Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Clinical Trial Medication method? Ulinastain treatment group? 400,000 IU ulinastatin or matching placebo will be reconstituted in 10 mL of 0.9% normal saline, and then dissolved in 100 mL of 0.9% normal saline every 8 hours for 10 days in a double-blind fashion. Intravenous infusion, The study drug will be infused intravenously over 1 hour. Placebo control group?Matching with medication Course?10 days Sample size? 348(174 patients of treatment group, 174 patients of control group) Sites? 15 Primary endpoint?The primary outcome measure for the study is death from all causes at 28-days. Secondary endpoints: Mortality rate at 90-days Mortality rate in ICU Mortality rate at hospital discharge ICU-free days in 28 days Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 1, 3, 6, 10,14, and 28 days after randomization Incidence and duration of supportive care for organ dysfunction including vasoactive agents, invasive or noninvasive mechanical ventilation, continuous renal replacement therapy(CRRT) Blood lactate concentration at 1, 3, 6 and 10 days after randomization Condition of fluid balance within 10 days after randomization High-sensitivity C-reactive protein (hs-CRP), IL-6, IL-10, TNF-? at 1, 3,6 and 10 days after randomization ADL level at hospital discharge Safety endpoints adverse events serious adverse events vital signs, complete blood counts, chemistry, electrocardiograms

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