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

Not Applicable

Completed

• Conditions: Cardiac Revascularization
• Interventions: Procedure: Coronary Artery Bypass Grafting

• Registration Number: NCT04639856
• Lead Sponsor: Armed Forces Institute of Cardiology, Pakistan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-15
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Status Verified: 2020-11
• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-20
• Last Update Submitted: 2020-11-20
• Study First Posted: 2020-11-23
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
on-pump CABG	Coronary Artery Bypass Grafting	CABG using Cardiopulmonary Bypass Machine
off-pump CABG	Coronary Artery Bypass Grafting	CABG without Cardiopulmonary Bypass Machine

Primary Outcome Measures

Name	Time	Method
ICU Stay	6 Months	post operative ICU stay in patients undergoing cardiac revascularization

Trial Locations

Locations (1)

Armed Forces Institute of Cardiology, Rawalpindi; 🇵🇰 Rawalpindi, Pakistan