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Completed

NCT Number: NCT00248885

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

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.

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Key information

Conditions

Coronary Artery Bypass Graft Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Hospital-Weill Cornell Medical College

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

  1. Cardiac morbidity

    Time frame: 6-months after surgery

  2. Neurologic morbidity

    Time frame: 6-months after surgery

  3. Mortality

    Time frame: 6-months after surgery

  4. Functional status

    Time frame: 6-months after surgery

  5. Neurocognitive function

    Time frame: 6-months after surgery

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Peri-Operative Morbidity and Quality of Life After CABG

Important dates

Study start
1991
Study completion
1994
First posted
Nov 4, 2005
Registry last updated
Apr 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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