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

Hamad Medical Corporation (HMC)

Status: Unknown

Conditions: Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator Decannulation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04678518

MRC-01-20-155

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

SIRS

Active Comparator group

Description:

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

Treatment:

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

NON-SIRS

Placebo Comparator group

Description:

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

Treatment:

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