Effects of Ulinastatin on Inflammatory Response During ECMO Support

NCT04990752 | Unknown FDA Drug

• 1 other identifier: NFEC-2021-154
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

ECMO; Inflammatory Response

Keywords

ulinastatin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Capillary leakage index

  change from admission to 5 days after ECMO support

• Renal function

  change from admission to 5 days after ECMO support

• Liver function

  change from admission to 5 days after ECMO support

• Myocardial injury indexes

  change from admission to 5 days after ECMO support

• Cardiac function

  change from admission to 5 days after ECMO support

Study Arms (2)

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

The control group

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

Interventions

ulinastatin DRUG

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 ulinastatin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Voluntarily signed informed consent;
• ≥18 years old;
• Patients have indications for ECMO support;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Shenzhen Hospital of Southern Medical University: collaborator
• Huadu District People's Hospital of Guangzhou: collaborator
• Foshan Hospital of Traditional Chinese Medicine: collaborator
• Dongguan People's Hospital: collaborator

Study Sites (1)

Nangfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

blood sample

MeSH Terms

Interventions

urinastatin

Study Officials

• Zhongqing Chen, doctor

  Nanfang Hosptial of Southern Medical University

  STUDY CHAIR

Central Study Contacts

Jie Wu, doctor

CONTACT

18052570742; 815897457@qq.com

Yuan Zhang, doctor

CONTACT

15626182275; m15626182275@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 4, 2021
• Study Start: July 26, 2021
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 4, 2021

Record last verified: 2021-06

Locations

CN (1)