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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Coronary Artery Bypass Graft Surgery

Treatments: Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00248885

0001004169 (Formerly 0100-006)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

248 participants in 2 patient groups

1

Active Comparator group

Description:

In this group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB.

Treatment:

Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass

2

Experimental group

Description:

In this group (High), the goal was to maintain MAP between 80-100 mm Hg during CPB.

Treatment:

Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass