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

NCT05391789 | Unknown Phase 3

• 1 other identifier: KY2021-924
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 would be recruited and randomly assigned to the ordinary dose group, high dose group and placebo control group according to the ratio of 1:1:1. The trial will be followed up on days 0, 1, 3, 5, 7 and 28. Sofa on day 7 compared with baseline and all-cause mortality on day 28 were investigated to explore the efficacy of ulinastatin in the treatment of adult sepsis patients with systemic inflammatory response syndrome.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• delta sofa, ΔSOFA

  Sequential organ failure asses(SOFA) of day 5 , compared with the baseline.

  Day 5

Secondary Outcomes (26)

• Sofa vs. baseline change in sofa at randomization (delta sofa, Δ SOFA）

  Day 1,3,7

• 28 day all-cause mortality

  Day 28

• ICU hospitalization days

  Day 28

• antibiotic use days

  Day 28

• SIRS days

  Day 28

Other Outcomes (6)

• adverse event

  Day 28

• Serious adverse events

  Day 28

• Vital signs

  Day 28

Study Arms (3)

normal dose

EXPERIMENTAL

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

high dose

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Interventions

Ulinastatin DRUG

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

high dose; normal dose

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• diagnosis of sepsis for less than 48 hours
• 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%)
• Obtained informed consent signed by the patient or authorized immediate family member

You may not qualify if:

• 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
• Severe chronic liver disease (Child-Pugh grade C), liver parenchymal lesions with obvious portal hypertension, acute liver failure
• Chronic renal failure, received dialysis treatment before being selected
• Severe coagulation function: ISTH-DIC score ≥ 5 points
• 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
• Have received Xuebijing, thymosin or gamma globulin treatment within 3 months before being selected for the study
• Others: allergies to study drugs, pregnancy, breast-feeding, participating in other clinical trials within 3 months, and other conditions deemed unsuitable by the investigator.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Jingan, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Sepsis

Interventions

urinastatin; Therapeutics

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenhong Wenhong, Professor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sen Wang, Doctor

CONTACT

+86 13636616175; wangsen329@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician, professor

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: May 26, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)