Peri-Operative Morbidity and Quality of Life After Coronary Artery Bypass Graft (CABG)

Not Applicable

Completed

• Conditions: Coronary Artery Bypass Graft Surgery
• Interventions: Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass

• Registration Number: NCT00248885
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.

Detailed Description

The objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.

Study Timeline

• Study Start: 1991-09
• Study Completion: 1994-09
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-04
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-10
• Last Update Posted: 2008-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

1. Patients had to be undergoing elective CABG, without concomitant valve or other cardiac surgery.
2. Patients also had to be able to perform the neuropsychologic tests, and to provide informed consent.

Exclusion Criteria

1. Patients who refused to participate in the study.
2. Patients who live too far away from NYC to be able to come back for follow up at six months post-operatively.
3. Patients who had either valvular replacement and aortic amd mitral an aneurysm repair, or other cardiothoracic surgery.
4. Patients who were unable to complete the neuropsychologic test.
5. Patient who were part of another CABG study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Regulating Mean Arterial Pressure during cardiopulmonary bypass	In this group (High), the goal was to maintain MAP between 80-100 mm Hg during CPB.
1	Regulating Mean Arterial Pressure during cardiopulmonary bypass	In this group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB.

Primary Outcome Measures

Name	Time	Method
Cardiac morbidity	6-months after surgery
Neurologic morbidity	6-months after surgery
Mortality	6-months after surgery
Functional status	6-months after surgery
Neurocognitive function	6-months after surgery

Trial Locations

Locations (1)

New York Presbyterian Hospital-Weill Cornell Medical College; 🇺🇸 New York, New York, United States