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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Peri-Operative Morbidity and Quality of Life After CABG

Conditions
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Coronary Artery Bypass Graft Surgery

Intervention / Treatment
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* Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* 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.<br>* Other names: Mean Arterial Pressure during cardiopulmonary bypass 50-60 mm/Hg (control) vs. 80-100 mm/Hg (experimental);|
| Experimental: 2<br>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<br>* 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.<br>* Other names: Mean Arterial Pressure during cardiopulmonary bypass 50-60 mm/Hg (control) vs. 80-100 mm/Hg (experimental);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery bypass graft surgery, Perioperative complications, Neurocognitive function, Quality of life, Blood pressure