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COMPLETED

NCT05391789

PHASE3

Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Clinical Efficacy of Ulinastatin for Treatment of Sepsis With Systemic Inflammatory Response Syndrome: a Multicenter, Randomized, Double-blind, Multi Dose and Placebo-controlled Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-11-10

Completion Date

2024-06-20

Last Updated

2026-09-23

Healthy Volunteers

Conditions

Sepsis

Interventions

DRUG

Ulinastatin

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

DRUG

Placebo

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.

Inclusion Criteria: 1. sepsis-3 specified by SCCM and ESICM 1) suspected or confirmed infection: diagnosed by a clinician 2) evidence of acute organ dysfunction: for patients without chronic organ dysfunction in the past (assuming a baseline SOFA score of 0): sofa ≥ 2 points from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection for patients with chronic organ dysfunction in the past (SOFA score should be based on baseline): the increase of sofa ≥ 2 points from 48 hours before diagnosis of infection to 24 hours after diagnosis of infection 2. diagnosis of sepsis for less than 48 hours 3. Systemic inflammatory response syndrome (SIRS) 1) body temperature \> 38 ℃ or \< 36 ℃ 2) heart rate \> 90 3) respiratory rate\> 20 4) WBC count \> 12 × 10 \^ 9 / L or \< 4 × 10\^9/L (\>12000/ μ L or \< 4000/ μ L or immature granulocytes \> 10%) 4. Obtained informed consent signed by the patient or authorized immediate family member Exclusion Criteria: 1. Congestive heart failure (NYHA heart function level 4), cerebrovascular accident or acute coronary syndrome within 3 months, cardiac arrest within 7 days of this hospitalization, non-infectious cardiogenic shock, uncontrolled acute bleeding 2. Severe chronic liver disease (Child-Pugh grade C), liver parenchymal lesions with obvious portal hypertension, acute liver failure 3. Chronic renal failure, received dialysis treatment before being selected 4. Severe coagulation function: ISTH-DIC score ≥ 5 points 5. Significant immune abnormality/injury: received organ or bone marrow transplantation within 3 months before screening, moderate to severe leukopenia such as neutrophils \<1.5×10\^9/L, received radiotherapy or chemotherapy within 3 months , HIV seropositivity, active blood/lymphatic system tumor 6. Have received Xuebijing, thymosin or gamma globulin treatment within 3 months before being selected for the study 7. Others: allergies to study drugs, pregnancy, breast-feeding, participating in other clinical trials within 3 months, and other conditions deemed unsuitable by the investigator.

Locations (1)

Huashan Hospital affiliated to Fudan University

Jingan, Shanghai Municipality, China