Inflammatory Markers Dynamics in Response to Extra-corporeal Membrane Oxygenator Decannulation

Not Applicable

• Conditions: Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator Decannulation
• Interventions: Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF

• Registration Number: NCT04678518
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

Extracorporeal membrane oxygenation (ECMO) aim at providing cardiac, respiratory support, or both. The use of ECMO could be associated with systemic inflammatory response syndrome (SIRS) at the time of initiation or the time of decannulation. There is an existing evidence to state that clinical criteria of SIRS accompany decannulation. We aim at proving this relation through studying the inflammatory markers changes before and after decannulation. The investigators will study all participants who require ECMO support in the heart hospital, all patient will be subjected to clinical evaluation of the SIRS criteria plus studying the inflammatory makers that will include IL1, IL2, IL6 and TNF before and after decannulation. Participants will be divided based on the SIRS criteria into 2 groups and both groups will be compared using Chi-Square analysis (Fisher tests if small sample size) or two tailed t-test, as appropriate

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-12-20
• Study First Posted: 2020-12-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-19
• Study Start: 2023-02-28
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ALL ECMO patients candidates for decannulation

Exclusion Criteria

• patients who have identified sepsis prior to decannulation, febrile patients, patient who receive steroids and patient who die within 48 hours after ECMO decannulation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NON-SIRS	Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF	Patients will be grouped according to the presence or absence of SIRS criteria into group II (Non-SIRS)
SIRS	Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF	Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS)

Primary Outcome Measures

Name	Time	Method
Cytokine changes	2 years	Cytokines changes: Interleukins (IL); IL1, IL2, IL6 and TNF 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)

Trial Locations

Locations (1)

Hamad medical corporation; 🇶🇦 Doha, DA, Qatar