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

Effects of Ulinastatin on Persistent Inflammatory Response During ECMO Support

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Response; ECMO
• Intervention / Treatment: Drug: ulinastatin

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.

• Study Type: Observational
• Enrollment (Anticipated): 144

Contacts and Locations

• Study Contact: Name: Jie Wu, doctor; Phone Number: 18052570742; Email: 815897457@qq.com
• Study Contact Backup: Name: Yuan Zhang, doctor; Phone Number: 15626182275; Email: m15626182275@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nangfang Hospital of Southern Medical University
      • Contact: Wenyuan Li, Dr; Phone Number: 020-61641888

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with indications for receiving ECMO support and who, at the clinician's discretion, need ECMO support.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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).
The control group; In the control group, patients were treated with conventional treatment without ulinastatin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Dongguan People's Hospital; Foshan Hospital of Traditional Chinese Medicine; Shenzhen Hospital of Southern Medical University; Huadu District People's Hospital of Guangzhou
• Investigators: Study Chair: Zhongqing Chen, doctor, Nanfang Hosptial of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: ulinastatin
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Trypsin Inhibitors; Urinastatin
• Other Study ID Numbers: NFEC-2021-154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No