Effects of Ulinastatin on Inflammatory Response During ECMO Support (Uli-ECMO)

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: ECMO; Inflammatory Response

Treatments: Drug: ulinastatin

Study type: Observational

Funder types: Other

Identifiers

NCT04990752

NFEC-2021-154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

144 participants in 2 patient groups

The ulinastatin group

Description:

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).

Treatment:

Drug: ulinastatin

The control group

Description:

In the control group, patients were treated with conventional treatment without ulinastatin.