Effects of Ulinastatin on Persistent Inflammatory Response During ECMO Support
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- CRP level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed informed consent;
- •≥18 years old;
- •Patients have indications for ECMO support;
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: ulinastatin (Drug)
结局指标
主要结局
CRP level
时间窗: change from admission to 5 days after ECMO support
The serum levels of CRP
IL-6 level, IL-10 level
时间窗: change from admission to 5 days after ECMO support
The serum levels of IL-6 and IL-10
TNF-α level
时间窗: change from admission to 5 days after ECMO support
The serum levels of TNF-α
次要结局
- Cardiac function(change from admission to 5 days after ECMO support)
- Capillary leakage index(change from admission to 5 days after ECMO support)
- Liver function(change from admission to 5 days after ECMO support)
- Incidence of new organ insufficiency/failure during ECMO support(during ECMO support)
- Infection(change from admission to 5 days after ECMO support)
- Mortality rate of in-hospital /28d/90d(90 days after admission)
- Myocardial injury indexes(change from admission to 5 days after ECMO support)
- Immunity(change from admission to 5 days after ECMO support)
- Duration of use of ECMO/length of hospital stay/length of ICU stay(through study completion)
- Renal function(change from admission to 5 days after ECMO support)