A Phase 3 interventional study of Ulinastatin and Placebo in Sepsis, sponsored by Huashan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Huashan Hospital · Phase 3, Interventional, and Treatment
Sepsis is a life-threatening organ dysfunction caused by the maladjusted response of the host to infection. It is a clinical syndrome with high mortality. Studies have confirmed that many cytokines play a vital role in the pathogenesis of sepsis. Ulinastatin (UTI) is a glycoprotein that exists in human blood and can be isolated and purified from human urine. It is a broad-spectrum protease inhibitor. Previous studies have shown that Ulinastatin may have the effect of treating sepsis.
120 septic patients with systemic inflammatory response syndrome were recruited and randomly assigned to the ordinary-dose group, high-dose group, or placebo in a 1:1:1 ratio. The trial was followed up on days 0, 1, 3, 5, 7 and 28. The primary outcome is the change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 5 (ΔSOFA). All-cause mortality at day 28 is a secondary outcome.
This completed multicenter randomized trial enrolled 120 adults with sepsis and systemic inflammatory response syndrome (SIRS). After informed consent, the enrollment day was Day 0. Participants were randomly assigned 1:1:1 to an ordinary-dose group, a high-dose group, or a placebo control group, and baseline clinical information was collected.
The ordinary-dose group received ulinastatin 400,000 units intravenously every 8 hours. The high-dose group received ulinastatin 800,000 units intravenously every 8 hours. The control group received an equal volume of 0.9% saline (50 mL) intravenously every 8 hours. When SIRS criteria were no longer met, the assigned dose (or matching placebo volume) was halved and continued; treatment lasted at least 3 days and up to 7 days.
Inclusion criteria:
1) Adults ≥18 and ≤80 years of age; 2) sepsis according to Sepsis-3; 3) sepsis diagnosis \<48 hours; 4) SIRS; 5) written informed consent from the patient or a legally authorized representative.
Exclusion criteria:
1) Congestive heart failure with NYHA class IV function, cerebrovascular accident or acute coronary syndrome within 3 months, in-hospital or recent (within 7 days) cardiac arrest, non-infectious cardiogenic shock, or uncontrolled acute bleeding; 2) severe chronic liver disease (Child-Pugh C), liver parenchymal disease with significant portal hypertension, or acute liver failure; 3) chronic renal failure with dialysis before enrollment; 4) severe coagulopathy (ISTH DIC score ≥5); 5) significant immune impairment (organ or bone marrow transplantation; moderate or severe leukopenia within 3 months before screening, e.g. neutrophils \<1.5×10\^9/L; radiotherapy or chemotherapy within 3 months; HIV seropositivity; active hematologic or lymphatic malignancy); 6) Xuebijing, thymosin, or gamma globulin within 3 months before enrollment; 7) allergy to study drug, pregnancy, lactation, participation in another clinical trial within 3 months, or other conditions judged by the investigator to preclude participation.
Follow-up visits were on days 0, 1, 3, 5, 7, and 28. The primary outcome is the change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 5 (ΔSOFA). Secondary outcomes include SOFA at other visits, 28-day all-cause mortality, ICU stay, duration of antibiotics, SIRS, vasoactive drugs, mechanical ventilation and CRRT, and laboratory measures of infection, inflammation, coagulation, liver and kidney function, neurological and mental status, and endothelial injury.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 120 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
Patients would be given 400000 units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days
Drug: Ulinastatin
Patients would be given 800000 units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days
Drug: Ulinastatin
Patients would be given 50 ml of 0.9% normal saline intravenously for at least 1 hour once every 8 hours.It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), continue to use it for 2 days, with a total course of treatment of at least 3 days.
Drug: Placebo
Patients would be given 400000 or 800000units of ulinastatin (specification: 100000 units / vial) dissolved in 50 ml of 0.9% normal saline intravenously for at least 1 hour, once every 8 hours. It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), halve the dose and continue to use it for 2 days, with a total course of treatment of at least 3 days
Also known as: Treatment
Patients would be given 50 ml of 0.9% normal saline intravenously for at least 1 hour once every 8 hours.It is evaluated by the attending doctor every day. When the patient does not have systemic inflammatory response syndrome (SIRS), continue to use it for 2 days, with a total course of treatment of at least 3 days.
Also known as: Control
delta sofa, ΔSOFA
Sequential organ failure asses(SOFA) of day 5 , compared with the baseline.
Time frame: Day 5
Sofa vs. baseline change in sofa at randomization (delta sofa, Δ SOFA）
Sequential Organ Failure Assessment
Time frame: Day 1,3,7
28 day all-cause mortality
28 day all-cause mortality
Time frame: Day 28
ICU hospitalization days
ICU hospitalization days
Time frame: Day 28
antibiotic use days
antibiotic use days
Time frame: Day 28
SIRS days
SIRS days
Time frame: Day 28
vasoactive drugs days
vasoactive drugs days
Time frame: Day 28
mechanical ventilation days
mechanical ventilation days
Time frame: Day 28
CRRT days
CRRT days
Time frame: Day 28
Blood routine
Blood routine
Time frame: Day 1,3,5,7
coagulation and fibrinolysis indexes: PT, PLT, D-dimer
coagulation and fibrinolysis indexes
Time frame: Day 1,3,5,7
DIC score
The ISTH group produced a simple scoring system for the diagnosis of DIC depending on the Platelet count, the PT, the fibrinogen level and critically the FDP/D-Dimer results. A person's ISTH DIC score ranges from 0 to 8. \<5 is suggestive of non-overt/low grade DIC. ≥5 means laboratory evidence is consistent with overt DIC
Time frame: Day 1,3,5,7
AST, ALT, bilirubin
Liver function
Time frame: Day 1,3,5,7
urine volume
urine volume
Time frame: Day 1,3,5,7
creatinine
creatinine
Time frame: Day 1,3,5,7
urea nitrogen
urea nitrogen
Time frame: Day 1,3,5,7
blood lactate
blood lactate
Time frame: Day 1,3,5,7
oxygenation index
oxygenation index
Time frame: Day 1,3,5,7
oxygen saturation
oxygen saturation
Time frame: Day 1,3,5,7
Glasgow Coma Scale
Glasgow Coma Scale. A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive). A lower score means a more serious condition.
Time frame: Day 1,3,5,7
days of delirium and coma
days of delirium and coma
Time frame: Day 1,3,5,7
APACHE-II on day 5
Acute Physiology and Chronic Health Evaluation
Time frame: Day 5
ADL on day 1,3,5,7;
Activities of Daily Living score
Time frame: Day 1,3,5,7
intercellular adhesion factor
Endothelial cell function
Time frame: Day 1,3,7
concentration of endothelial cell specific molecules
Endothelial cell function
Time frame: Day 1,3,7
heparan sulfate
Endothelial cell function
Time frame: Day 1,3,7
lymphocyte subsets and inflammatory factor levels (IL-6, IL-10, CRP, PCT, TNF- α、 HMGB-1）
Immune and inflammatory indexes
Time frame: Day 1,3,7
adverse event
safety endpoint
Time frame: Day 28
Serious adverse events
safety endpoint
Time frame: Day 28
Vital signs
any abnormalities in vital signs
Time frame: Day 28
Blood biochemistry
safety endpoint
Time frame: Day 28
physical examination results
any abnormalities in physical examination results
Time frame: Day 28
electrocardiogram
any abnormalities in electrocardiogram
Time frame: Day 28
Plan to share: No
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Huashan Hospital