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Effects of Ulinastatin on Inflammatory Response During ECMO Support

NCT04990752 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2021-08-04

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Shenzhen Hospital of Southern Medical University

    collaborator OTHER

  • Huadu District People's Hospital of Guangzhou

    collaborator OTHER

  • Foshan Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Zhongqing Chen, doctor · Nanfang Hosptial of Southern Medical University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2023-03-01
Completion
2023-06-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04990752 on ClinicalTrials.gov