Improving Outcomes and Quality of Life After CABG

March 31, 2008 updated by: Weill Medical College of Cornell University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

412

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital-Weill Medical Center

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

35 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life
Mortality
Cardiac morbidity
Neurologic morbidity
Neurocognitive deterioration

Secondary Outcome Measures

Outcome Measure
• 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.

Collaborators and Investigators

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

Sponsor

Weill Medical College of Cornell University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Karl Krieger, MD, Weill Medical College of Cornell University

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

December 1, 1996

Study Completion

December 1, 1999

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9407000398 Formerly 0794-502CR

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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