Coronary Artery Bypass Graft Surgery
Conditions
Keywords
Coronary artery bypass graft surgery, Perioperative complications, Neurocognitive function, Quality of life, Blood pressure
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.
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.
Interventions
PROCEDURERegulating 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed