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

Sponsor

Hamad Medical Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04678518

Collaborator

(none)

Enrollment

Locations

Arms

10.1

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator Decannulation	Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

The study will be conducted in the Heart Hospital to be conducted from the time of ethical approval for 24 months. The clinical characterization of post decannulation SIRS when patient fulfill 2 out of 3 criteria, fever (temperature >38.3 Celsius), leukocytosis (white blood cell [WBC] >12,000, or > 25% increase from pre-procedure baseline), and need for escalation of vasopressors post decannulation. The rest of SIRS criteria will not be used as it is subjected to changes due to contribution from the inotropes, sedation, pain level and ventilation settings. [12] Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS) and group II (no-SIRS). Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours) both groups will be compared.The study will be conducted in the Heart Hospital to be conducted from the time of ethical approval for 24 months. The clinical characterization of post decannulation SIRS when patient fulfill 2 out of 3 criteria, fever (temperature >38.3 Celsius), leukocytosis (white blood cell [WBC] >12,000, or > 25% increase from pre-procedure baseline), and need for escalation of vasopressors post decannulation. The rest of SIRS criteria will not be used as it is subjected to changes due to contribution from the inotropes, sedation, pain level and ventilation settings. [12] Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS) and group II (no-SIRS). Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours) both groups will be compared.

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SIRS Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS)	Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)
Placebo Comparator: NON-SIRS Patients will be grouped according to the presence or absence of SIRS criteria into group II (Non-SIRS)	Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)

Arm

Intervention/Treatment

Active Comparator: SIRS

Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS)

Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF

1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)

Placebo Comparator: NON-SIRS

Patients will be grouped according to the presence or absence of SIRS criteria into group II (Non-SIRS)

Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF

1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)

Outcome Measures

Primary Outcome Measures

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)

Other Outcome Measures

Length of stay in ICU [First 48 hours after ECMO initiation]
Length of mechanical ventilation [First 48 hours after ECMO initiation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamad medical corporation	Doha	DA	Qatar	3050
2	Hamad medical corporation	Doha	DA	Qatar	3050

Sponsors and Collaborators

Hamad Medical Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hamad Medical Corporation

ClinicalTrials.gov Identifier:

NCT04678518

Other Study ID Numbers:

MRC-01-20-155

First Posted:

Dec 22, 2020

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 19, 2022