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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04990752
Other study ID # NFEC-2021-154
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 26, 2021
Est. completion date June 1, 2023

Study information

Verified date June 2021
Source Nanfang Hospital of Southern Medical University
Contact Jie Wu, doctor
Phone 18052570742
Email 815897457@qq.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date June 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
China Nangfang Hospital of Southern Medical University Guangzhou Guangdong

Sponsors (5)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University Dongguan People's Hospital, Foshan Hospital of Traditional Chinese Medicine, Huadu District People's Hospital of Guangzhou, Shenzhen Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CRP level The serum levels of CRP change from admission to 5 days after ECMO support
Primary IL-6 level, IL-10 level The serum levels of IL-6 and IL-10 change from admission to 5 days after ECMO support
Primary TNF-a level The serum levels of TNF-a change from admission to 5 days after ECMO support
Secondary Capillary leakage index CRP(mg/dl)/ALB(g/L) change from admission to 5 days after ECMO support
Secondary Renal function The serum levels of creatinine change from admission to 5 days after ECMO support
Secondary Liver function The serum levels of ALTand AST change from admission to 5 days after ECMO support
Secondary Myocardial injury indexes The serum levels of cTnT and CK-MB change from admission to 5 days after ECMO support
Secondary Cardiac function The serum levels of NT-Pro-BNP change from admission to 5 days after ECMO support
Secondary Infection The serum levels of PCT change from admission to 5 days after ECMO support
Secondary Immunity The serum levels of LYM and WBC change from admission to 5 days after ECMO support
Secondary Incidence of new organ insufficiency/failure during ECMO support Incidence of new organ insufficiency/failure during ECMO support during ECMO support
Secondary 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
Secondary Mortality rate of in-hospital /28d/90d Mortality rate of in-hospital /28d/90d 90 days after admission
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