Effects of Ulinastatin on Inflammatory Response During ECMO Support

• Conditions: Inflammatory Response; ECMO
• Interventions: Drug: ulinastatin

• Registration Number: NCT04990752
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

This study is a multicenter, prospective, observational cohort study. The subjects were patients who received ECMO support. According to whether ulinastatin is used in the treatment regimen (determined by the competent doctor according to the patient's condition), the patients were divided into the ulinastatin and control groups. In the ulinastatin group, ulinastatin was used for inflammation management and organ protection early before ECMO was started. Baseline data and inflammatory markers (CRP, IL-6, IL-10, TNF-α), capillary leakage markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3, and 5 days after the start of ECMO support, and patients were followed up on the 28th and 90th days.

Detailed Description

This study is a multicenter, prospective, observational cohort study. The subjects were patients who received ECMO support. According to whether ulinastatin is used in the treatment regimen (determined by the competent doctor according to the patient's condition), the patients were divided into the ulinastatin and control groups. 144 subjects were enrolled, including 72 subjects in the ulinastatin group and 72 subjects in the control group. In the ulinastatin group, ulinastatin was used for inflammation management and organ protection early before ECMO was started. The recommended clinical routine dosage of ulinastatin is 300,000 IU, q8h (continuous administration for more than 5 days). Baseline data and inflammatory markers (CRP, IL-6, IL-10, TNF-α), capillary leakage markers, routine test results, duration of ECMO use/length of hospital stay/length of ICU stay were recorded at 1, 3, and 5 days after the start of ECMO support, and patients were followed up on the 28th and 90th days.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-07-15
• Study Start: 2021-07-26
• Study First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Study First Posted: 2021-08-04
• Last Update Posted: 2021-08-04
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Voluntarily signed informed consent;
• ≥18 years old;
• Patients have indications for ECMO support;

Exclusion Criteria

• Pregnancy or lactation;
• Withdrawal of ECMO or death of the patient within 48 hours of the start of operation;
• Solid-organ or bone marrow transplant recipients;
• Previous history of allergy to ulinastatin or any ingredient or preservative;
• Patients with autoimmune diseases, tumors, or patients receiving high doses of glucocorticoids or immunosuppressant therapy within 2 months;
• Patients judged by the investigator to be unsuitable for participation in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The ulinastatin group	ulinastatin	In the ulinastatin group, ulinastatin was used for inflammation management and organ protection early before ECMO was started. The recommended dosage of ulinastatin is 300,000 IU, q8h (Continuous administration for more than 5 days).

Primary Outcome Measures

Name	Time	Method
CRP level	change from admission to 5 days after ECMO support	The serum levels of CRP
IL-6 level, IL-10 level	change from admission to 5 days after ECMO support	The serum levels of IL-6 and IL-10
TNF-α level	change from admission to 5 days after ECMO support	The serum levels of TNF-α

Secondary Outcome Measures

Name	Time	Method
Myocardial injury indexes	change from admission to 5 days after ECMO support	The serum levels of cTnT and CK-MB
Capillary leakage index	change from admission to 5 days after ECMO support	CRP(mg/dl)/ALB(g/L)
Liver function	change from admission to 5 days after ECMO support	The serum levels of ALTand AST
Incidence of new organ insufficiency/failure during ECMO support	during ECMO support	Incidence of new organ insufficiency/failure during ECMO support
Infection	change from admission to 5 days after ECMO support	The serum levels of PCT
Mortality rate of in-hospital /28d/90d	90 days after admission	Mortality rate of in-hospital /28d/90d
Immunity	change from admission to 5 days after ECMO support	The serum levels of LYM and WBC
Renal function	change from admission to 5 days after ECMO support	The serum levels of creatinine
Cardiac function	change from admission to 5 days after ECMO support	The serum levels of NT-Pro-BNP
Duration of use of ECMO/length of hospital stay/length of ICU stay	through study completion	Duration of use of ECMO/length of hospital stay/length of ICU stay

Trial Locations

Locations (1)

Nangfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China