ECMO, Inflammatory Response
Conditions
Keywords
ulinastatin
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.
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.
Interventions
DRUGulinastatin
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).
Sponsors
Shenzhen Hospital of Southern Medical University
Huadu District People's Hospital of Guangzhou
Foshan Hospital of Traditional Chinese Medicine
Dongguan People's Hospital
Nanfang Hospital, Southern Medical University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Capillary leakage index | change from admission to 5 days after ECMO support | CRP(mg/dl)/ALB(g/L) |
| 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 |
| Immunity | change from admission to 5 days after ECMO support | The serum levels of LYM and WBC |
| 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 |
Countries
China
Contacts
Primary ContactJie Wu, doctor
Backup ContactYuan Zhang, doctor
Outcome results
None listed