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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

NCT ID: NCT04639856

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-15

Study Completion Date

2019-01-15

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.

Detailed Description

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Conditions

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Cardiac Revascularization

Keywords

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Coronary Artery Bypass Grafting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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on-pump CABG

CABG using Cardiopulmonary Bypass Machine

Group Type ACTIVE_COMPARATOR

Coronary Artery Bypass Grafting

Intervention Type PROCEDURE

on-pump vs off pump Coronary artery Bypass Grafting

off-pump CABG

CABG without Cardiopulmonary Bypass Machine

Group Type ACTIVE_COMPARATOR

Coronary Artery Bypass Grafting

Intervention Type PROCEDURE

on-pump vs off pump Coronary artery Bypass Grafting

Interventions

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Coronary Artery Bypass Grafting

on-pump vs off pump Coronary artery Bypass Grafting

Intervention Type PROCEDURE

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Armed Forces Institute of Cardiology, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Bilal

Cardiac Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Armed Forces Institute of Cardiology, Rawalpindi

Rawalpindi, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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AFIC-IERB-SOP-15

Identifier Type: -

Identifier Source: org_study_id