Improving Outcomes and Quality of Life After CABG

Not Applicable

Completed

• Conditions: Coronary Artery Bypass Graft Surgery Patients

• Registration Number: NCT00256620
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 1996-12
• Study Completion: 1999-12
• Study First Submitted: 2005-11-17
• Study First Submitted QC: 2005-11-17
• Study First Posted: 2005-11-21
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-31
• Last Update Posted: 2008-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

• All patients undergoing primary elective/urgent coronary artery bypass graft (CABG) surgery.

Exclusion Criteria

• Patients who elect not to participate in the study
• Patients undergoing valve replacement or other cardiovascular surgical procedures
• Patients who are not fluent in English
• Patient who cannot provide informed written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Quality of life
Cardiac morbidity
Mortality
Neurologic morbidity
Neurocognitive deterioration

Secondary Outcome Measures

Name	Time	Method
• To correlate TEE and epiaortic scanning for aortic atheroma with transthoracic echocardiography (TTE) in order to develop a non-invasive screening tool.
• To provide data on the mechanism of perioperative neurologic and cognitive complications in order to design other specific intervention to reduce postoperative morbidity.
• 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 evaluate the prognostic importance of severe atheromatous disease of the descending aorta as found on transesophageal echocardiography (TEE) as a predictor of neurologic events.

Trial Locations

Locations (1)

New York Presbyterian Hospital-Weill Medical Center; 🇺🇸 New York, New York, United States