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.
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 Type
OBSERVATIONAL
Enrollment
144
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).
Nangfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGCRP level
The serum levels of CRP
Time frame: change from admission to 5 days after ECMO support
IL-6 level, IL-10 level
The serum levels of IL-6 and IL-10
Time frame: change from admission to 5 days after ECMO support
TNF-α level
The serum levels of TNF-α
Time frame: change from admission to 5 days after ECMO support
Capillary leakage index
CRP(mg/dl)/ALB(g/L)
Time frame: change from admission to 5 days after ECMO support
Renal function
The serum levels of creatinine
Time frame: change from admission to 5 days after ECMO support
Liver function
The serum levels of ALTand AST
Time frame: change from admission to 5 days after ECMO support
Myocardial injury indexes
The serum levels of cTnT and CK-MB
Time frame: change from admission to 5 days after ECMO support
Cardiac function
The serum levels of NT-Pro-BNP
Time frame: change from admission to 5 days after ECMO support
Infection
The serum levels of PCT
Time frame: change from admission to 5 days after ECMO support
Immunity
The serum levels of LYM and WBC
Time frame: 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
Time frame: 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
Time frame: through study completion
Mortality rate of in-hospital /28d/90d
Mortality rate of in-hospital /28d/90d
Time frame: 90 days after admission
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