Improving Outcomes and Quality of Life After CABG

May 12, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
Among patients undergoing elective primary coronary artery bypass graft (CABG), the principal objective of this randomized trial was to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality, and post-operative deterioration in patients' quality of life as measured by the SF-36.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Surgical myocardial revascularization (CABG) is an effective treatment for triple vessel and left main coronary artery disease used for thousands of patients annually in the United States. CABG certainly prolongs life, and data demonstrates that it improves functional status for the majority of patients. The intervention in this trial is based upon the outcomes of the investigators' first trial, which showed a benefit to maintaining mean intra-bypass mean arterial pressure (MAP) at 65 mm Hg in the high MAP group vs. 52 mm Hg in the low MAP group. Intra-bypass MAPs corrected for intervals less than full flow were 81 mm Hg for the high group and 59 mm Hg for the low MAP group. Cardiac and neurologic morbidity and mortality were 4.8 percent in the high MAP group versus 12.9 percent in the low MAP group (p=.026). All adverse outcomes were lower in the high MAP group (16.1 percent) than in the low MAP group (27.4 percent). Data from the previous study also suggests that outcomes may be further improved by maintaining intra-bypass MAP close to the patient's preoperative MAP. This is consistent with the investigators previous work in non-cardiac surgery, which shows that maintaining MAP within patient's usual autoregulatory range is associated with lower cardiac and renal complication rates. This study will determine whether refining the approach to hemodynamic management will further improve patient outcomes after coronary revascularization.

DESIGN NARRATIVE:

The First Clinical Study

During the first three years of grant support, from August, 1991 to November, 1995, clinical research was conducted on a comparison of intraoperative high versus low mean arterial pressure (MAP) on outcomes after coronary artery bypass. In this study, 248 patients undergoing primary, nonemergency coronary bypass were randomized to either low (n = 124) or high (n = 124) mean arterial pressure during cardiopulmonary bypass. The impact of the mean arterial pressure strategies on the following outcomes was assessed: mortality, cardiac morbidity, neurologic morbidity, cognitive deterioration, and changes in quality of life. All patients were observed prospectively to six months after the operation. Results are described under the Results Section.

Second Clinical Study

The second clinical study under grant R01HL44719, began in December, 1995 and was a prospective trial of 412 patients who were evaluated pre-operatively, monitored intra-operatively and followed post-operatively according to a standardized surveillance protocol. Patients were randomized to two forms of hemodynamic management during cardiopulmonary bypass. In one group, the intra-operative mean arterial pressure (MAP) during bypass was maintained at 65 mm Hg (or 81 mm Hg at full flow), thus employing the most effective strategy from the investigators' first trial. In the second group, the intra-operative MAP was maintained at their pre-operative MAP (but below 90 mm Hg), a strategy supported by data from the first trial. The principal outcome was the occurrence of any one of the following: mortality at six months, major cardiopulmonary morbidity (i.e., myocardial infarction, pulmonary edema, cardiogenic shock or low flow state), cognitive complications (defined by a summary definition which included improvement and decline on neuropsychologic tests of memory, psychomotor/attention, and linguistic function), major neurologic complications (i.e., new focal deficits, such as hemiplegia, aphasia, cortical blindness) and significant deterioration in functional status at six months postoperatively. The long term objective was to preserve and further improve the quality of life after CABG.

Although the study was described as a clinical trial, the Behavioral Medicine Study Section defined it as clinical research, not a NIH-defined Phase III trial.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Mary Charlson, Weill Medical College of Cornell University

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1991

Study Completion (Actual)

November 1, 2000

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

January 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4194
  • R01HL044719 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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