Effects of Ulinastatin on Inflammatory Response During ECMO Support

Inflammatory Response Clinical Trial

— Uli-ECMO  

Official title:

Effects of Ulinastatin on Persistent Inflammatory Response During ECMO Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990752
• Other study ID #: NFEC-2021-154
• Status: Recruiting
• Start date: July 26, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jie Wu, doctor
• Phone: 18052570742
• Email: 815897457[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ECMO
• Inflammatory Response

Intervention

Drug:
• ulinastatin
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).

Locations

Country	Name	City	State
China	Nangfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Dongguan People's Hospital, Foshan Hospital of Traditional Chinese Medicine, Huadu District People's Hospital of Guangzhou, Shenzhen Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRP level	The serum levels of CRP	change from admission to 5 days after ECMO support
Primary	IL-6 level, IL-10 level	The serum levels of IL-6 and IL-10	change from admission to 5 days after ECMO support
Primary	TNF-a level	The serum levels of TNF-a	change from admission to 5 days after ECMO support
Secondary	Capillary leakage index	CRP(mg/dl)/ALB(g/L)	change from admission to 5 days after ECMO support
Secondary	Renal function	The serum levels of creatinine	change from admission to 5 days after ECMO support
Secondary	Liver function	The serum levels of ALTand AST	change from admission to 5 days after ECMO support
Secondary	Myocardial injury indexes	The serum levels of cTnT and CK-MB	change from admission to 5 days after ECMO support
Secondary	Cardiac function	The serum levels of NT-Pro-BNP	change from admission to 5 days after ECMO support
Secondary	Infection	The serum levels of PCT	change from admission to 5 days after ECMO support
Secondary	Immunity	The serum levels of LYM and WBC	change from admission to 5 days after ECMO support
Secondary	Incidence of new organ insufficiency/failure during ECMO support	Incidence of new organ insufficiency/failure during ECMO support	during ECMO support
Secondary	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
Secondary	Mortality rate of in-hospital /28d/90d	Mortality rate of in-hospital /28d/90d	90 days after admission