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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Revascularization
• Intervention / Treatment: Procedure: Coronary Artery Bypass Grafting

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Rawalpindi, Pakistan, 44000
    • Armed Forces Institute of Cardiology, Rawalpindi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Armed Forces Institute of Cardiology, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Coronary Artery Bypass Grafting
• Other Study ID Numbers: AFIC-IERB-SOP-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No