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

Study Overview
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Brief Summary
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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

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

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

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SIRS<br>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<br>* 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)<br>|
| Placebo Comparator: NON-SIRS<br>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<br>* 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine changes | 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) | 2 years |