Effects of Ulinastatin on Inflammatory Response During ECMO Support

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Ulinastatin on Persistent Inflammatory Response During ECMO Support

Conditions
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ECMO, Inflammatory Response

Intervention / Treatment
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* Drug: ulinastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The ulinastatin group<br>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). | Drug: ulinastatin<br>* In the ulinastatin group, early application of ulinastatin was performed for inflammation management and organ protection before ECMO initiation.The recommended clinical routine dosage of ulinastatin is 300,000 IU, q8h (continuous administration for more than 5 days).<br>|
| The control group<br>In the control group, patients were treated with conventional treatment without ulinastatin. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP level | The serum levels of CRP | change from admission to 5 days after ECMO support | 
| IL-6 level, IL-10 level | The serum levels of IL-6 and IL-10 | change from admission to 5 days after ECMO support | 
| TNF-α level | The serum levels of TNF-α | change from admission to 5 days after ECMO support | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulinastatin