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

Coronary Artery Bypass Graft Surgery Clinical Trial

Official title:

Peri-Operative Morbidity and Quality of Life After CABG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248885
• Other study ID #: 0001004169 (Formerly 0100-006)
• Status: Completed
• Phase: N/A
• First received: November 3, 2005
• Last updated: April 10, 2008
• Start date: September 1991
• Est. completion date: September 1994

Study information

• Verified date: April 2008
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: September 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery

Intervention

Procedure:
• Regulating Mean Arterial Pressure during cardiopulmonary bypass
Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital-Weill Cornell Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac morbidity		6-months after surgery	No
Primary	Neurologic morbidity		6-months after surgery	No
Primary	Mortality		6-months after surgery	No
Primary	Functional status		6-months after surgery	No
Primary	Neurocognitive function		6-months after surgery	No