Improving Outcomes and Quality of Life After CABG

NCT ID: NCT00256620

Last Updated: 2008-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-12-31
• Study Completion Date: 1999-12-31

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.

Conditions

Coronary Artery Bypass Graft Surgery Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Weill Cornell Medical College

Principal Investigators

Mary E Charlson, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Karl Krieger, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York Presbyterian Hospital-Weill Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

9407000398 Formerly 0794-502CR

Identifier Type: -

Identifier Source: org_study_id