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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00248885
First received: November 3, 2005
Last updated: April 10, 2008
Last verified: April 2008
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Bypass Graft Surgery
 Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Peri-Operative Morbidity and Quality of Life After CABG

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Cardiac morbidity [ Time Frame: 6-months after surgery ] [ Designated as safety issue: No ]
  • Neurologic morbidity [ Time Frame: 6-months after surgery ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 6-months after surgery ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: 6-months after surgery ] [ Designated as safety issue: No ]
  • Neurocognitive function [ Time Frame: 6-months after surgery ] [ Designated as safety issue: No ]

Enrollment: 248
Study Start Date: September 1991
Study Completion Date: September 1994
Arms Assigned Interventions
Active Comparator: 1
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
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.
Other Name: Mean Arterial Pressure during cardiopulmonary bypass 50-60 mm/Hg (control) vs. 80-100 mm/Hg (experimental)
Experimental: 2
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
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.
Other Name: Mean Arterial Pressure during cardiopulmonary bypass 50-60 mm/Hg (control) vs. 80-100 mm/Hg (experimental)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248885

Locations
United States, New York
New York Presbyterian Hospital-Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Mary E Charlson, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Mary E. Charlson, Weill Cornell. Medical College
ClinicalTrials.gov Identifier: NCT00248885     History of Changes
Other Study ID Numbers: 0001004169 (Formerly 0100-006)
Study First Received: November 3, 2005
Last Updated: April 10, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Coronary artery bypass graft surgery
Perioperative complications
Neurocognitive function
Quality of life
Blood pressure

ClinicalTrials.gov processed this record on May 19, 2013