Last updated on February 2018

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


Brief description of study

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

Detailed Study Description

Investigational drugUlinastain 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 InvestigatorProfessor 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 groupMatching with medication

Course10 days

Sample size 348(174 patients of treatment group, 174 patients of control group)

Sites 15

Primary endpointThe 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

Clinical Study Identifier: NCT02647554

Contact Investigators or Research Sites near you

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Bin Du, MD

Peking Union Medical College Hospital
Beijing, China
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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