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-α 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
A Prospective, Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Trial of Ulinastatin Treatment in Adult Patients with Sepsis and Septic Shock in China