ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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Coronary artery bypass graft (CABG) surgery can result in severe postoperative complications, such as renal and pulmonary failure. In about 80% of the cases worldwide, it is currently performed with cardiopulmonary bypass (CPB) with cardiac arrest. Cardiopulmonary bypass leads to a systemic inflammatory response, which may be induced by the contact of circulating blood with artificial surfaces of the extracorporeal circuit.[1] To reduce postoperative complications caused by systemic inflammation, off-pump CABG was reintroduced into clinical practice in the early 1990s. During off-pump surgery, the coronary artery grafts are placed on coronaries of a beating heart, thereby avoiding aortic cross clamping and CPB. [1] There are many studies and debates about the two approaches to cardiac revascularization via CABG. This study aims to answer the question as to difference in the ICU stay of patients with low ejection fraction undergoing cardiac revascularization bet ween off pump and on pump coronary artery bypass grafting and better treatment option shall be adopted in future.

Official Title
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ICU Stay in Patients With Low Ejection Fraction Undergoing Cardiac Revascularization: Comparison of On-pump vs Off-pump Coronary Artery Bypass Grafting

Conditions
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Cardiac Revascularization

Intervention / Treatment
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* Procedure: Coronary Artery Bypass Grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients of either gender between the ages of 40 to 80 Ejection fraction of less than or equal to 35% undergoing CABG. undergoing CABG. Exclusion Criteria: Patients with ejection fraction of more than 35% Patients with previous history of cardiac revascularization Patients with previous history of chronic kidney disease and obstructive sleep apnea.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: on-pump CABG<br>CABG using Cardiopulmonary Bypass Machine | Procedure: Coronary Artery Bypass Grafting<br>* on-pump vs off pump Coronary artery Bypass Grafting<br>|
| Active Comparator: off-pump CABG<br>CABG without Cardiopulmonary Bypass Machine | Procedure: Coronary Artery Bypass Grafting<br>* on-pump vs off pump Coronary artery Bypass Grafting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Stay | post operative ICU stay in patients undergoing cardiac revascularization | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Bypass Grafting