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| Name | Class |
|---|---|
| Shenzhen Hospital of Southern Medical University | OTHER |
| Huadu District People's Hospital of Guangzhou | OTHER |
| Foshan Hospital of Traditional Chinese Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| The control group | In the control group, patients were treated with conventional treatment without ulinastatin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ulinastatin | Drug | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indications for receiving ECMO support and who, at the clinician's discretion, need ECMO support.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wu, doctor | Contact | 18052570742 | 815897457@qq.com | |
| Yuan Zhang, doctor | Contact | 15626182275 | m15626182275@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhongqing Chen, doctor | Nanfang Hosptial of Southern Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nangfang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| C028665 | urinastatin |
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| Dongguan People's Hospital |
| OTHER_GOV |
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blood sample
|
| 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 |