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Improving Outcomes and Quality of Life After CABG

NCT ID: NCT00256620

Last Updated: 2008-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Coronary Artery Bypass Graft Surgery Patients

Keywords

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Cardiopulmonary bypass Coronary artery disease Cardiac morbidity Neurologic morbidity Neurocognitive function Autoregulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized

Intervention Type PROCEDURE

Eligibility Criteria

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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

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Weill Cornell Medical College

Principal Investigators

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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

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New York Presbyterian Hospital-Weill Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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9407000398 Formerly 0794-502CR

Identifier Type: -

Identifier Source: org_study_id