Improving Outcomes and Quality of Life After CABG
The principal objective to this randomized trial is to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass among patients undergoing primary elective coronary artery bypass graft (CABG) surgery in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and post-operative deterioration in the patient's quality of life as measured by the seven domains of SF-36 Health Survey (bodily pain, health perceptions, energy, and mental, physical, social and role function).
Coronary Artery Bypass Graft Surgery Patients
Procedure: Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Improving Outcomes and Quality of Life After CABG|
- Quality of life
- Cardiac morbidity
- Neurologic morbidity
- Neurocognitive deterioration
- • To evaluate the prognostic importance of severe atheromatous disease of the descending aorta as found on transesophageal echocardiography (TEE) as a predictor of neurologic events.
- • To correlate TEE and epiaortic scanning for aortic atheroma with transthoracic echocardiography (TTE) in order to develop a non-invasive screening tool.
- • To assess the clinical significance of persistent post-operative depression as measured by the CES-D by using a structured clinical interview and to evaluate the relationship between pre-operative depression and the occurrence of cardiac, neurologic a
- • To provide data on the mechanism of perioperative neurologic and cognitive complications in order to design other specific intervention to reduce postoperative morbidity.
|Study Start Date:||December 1996|
|Estimated Study Completion Date:||December 1999|
In one group, mean arterial pressure (MAP) was 65 mmHg. In the other, the MAP target was determined by the patients usual preoperative MAP. Thus, the trial will evaluate whether tailoring the MAP target for the period of cardiopulmonary bypass to within 10 mmHg of the patients usual MAP, but < 90 mmHg (and thus achieving pressures during bypass within the patients usual autoregulatory range) reduces major neurologic and cardiac morbidity and mortality, as well as cognitive complications, thereby improving post-operative quality of life.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256620
|United States, New York|
|New York Presbyterian Hospital-Weill Medical Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Mary E Charlson, MD||Weill Medical College of Cornell University|
|Principal Investigator:||Karl Krieger, MD||Weill Medical College of Cornell University|