Uli-ECMO: Effects of Ulinastatin on Inflammatory Response During ECMO Support
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| The ulinastatin group 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
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).
|
| The control group In the control group, patients were treated with conventional treatment without ulinastatin. |
Outcome Measures
Primary Outcome Measures
- 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
- Capillary leakage index [change from admission to 5 days after ECMO support]
CRP(mg/dl)/ALB(g/L)
- Renal function [change from admission to 5 days after ECMO support]
The serum levels of creatinine
- Liver function [change from admission to 5 days after ECMO support]
The serum levels of ALTand AST
- Myocardial injury indexes [change from admission to 5 days after ECMO support]
The serum levels of cTnT and CK-MB
- Cardiac function [change from admission to 5 days after ECMO support]
The serum levels of NT-Pro-BNP
- Infection [change from admission to 5 days after ECMO support]
The serum levels of PCT
- Immunity [change from admission to 5 days after ECMO support]
The serum levels of LYM and WBC
- Incidence of new organ insufficiency/failure during ECMO support [during ECMO support]
Incidence of new organ insufficiency/failure during ECMO support
- 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
- Mortality rate of in-hospital /28d/90d [90 days after admission]
Mortality rate of in-hospital /28d/90d
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntarily signed informed consent;
-
≥18 years old;
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Patients have indications for ECMO support;
Exclusion Criteria:
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Pregnancy or lactation;
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Withdrawal of ECMO or death of the patient within 48 hours of the start of operation;
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Solid-organ or bone marrow transplant recipients;
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Previous history of allergy to ulinastatin or any ingredient or preservative;
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Patients with autoimmune diseases, tumors, or patients receiving high doses of glucocorticoids or immunosuppressant therapy within 2 months;
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Patients judged by the investigator to be unsuitable for participation in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nangfang Hospital of Southern Medical University | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- Shenzhen Hospital of Southern Medical University
- Huadu District People's Hospital of Guangzhou
- Foshan Hospital of Traditional Chinese Medicine
- Dongguan People's Hospital
Investigators
- Study Chair: Zhongqing Chen, doctor, Nanfang Hosptial of Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NFEC-2021-154