Ulinastatin Treatment in Adult Patients With Sepsis and Septic Shock in China
Condition: Sepsis; Septic Shock
MeSH terms: Sepsis; Toxemia; Shock, Septic; Shock
Study type: Interventional
Phase: Phase 4

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

Detailed 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 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
    

Intervention name(s): ulinastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ulinastatin 400,000 IU every 8 hours for 10 days; matching placebo every 8 hours for 10 days
Other intervention name(s): urinary trypsin inhibitor
Intervention MeSH terms: Urinastatin; Trypsin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sepsis; septic shock; Ulinastatin; adult; China