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

NCT00248885 | Completed

• 1 other identifier: 0001004169 (Formerly 0100-006)
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Graft Surgery

Keywords

Coronary artery bypass graft surgery; Perioperative complications; Neurocognitive function; Quality of life; Blood pressure

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass

2

EXPERIMENTAL

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

Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass

Interventions

Regulating Mean Arterial Pressure during cardiopulmonary bypass PROCEDURE

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.

Also known as: Mean Arterial Pressure during cardiopulmonary bypass 50-60 mm/Hg (control) vs. 80-100 mm/Hg (experimental)

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

New York Presbyterian Hospital-Weill Cornell Medical College

New York, New York, 10065, United States

Location

Study Officials

• Mary E Charlson, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: September 1, 1991
• Study Completion: September 1, 1994
• Last Updated: April 11, 2008

Record last verified: 2008-04

Locations

US (1)