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Peri-Operative Morbidity and Quality of Life After Coronary Artery Bypass Graft (CABG)

NCT ID: NCT00248885

Last Updated: 2008-04-11

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

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-09-30

Study Completion Date

1994-09-30

Brief Summary

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It is the long term objective of this study to preserve or improve the quality of life and to prevent deterioration in physical and mental function following myocardial revascularization among bypass surgery patients.

Detailed Description

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The objective of this study is to compare the efficacy of two strategies of intra-operative hemodynamic management in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and postoperative deterioration in the patient's quality of life.

Conditions

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Coronary Artery Bypass Graft Surgery

Keywords

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Coronary artery bypass graft surgery Perioperative complications Neurocognitive function Quality of life Blood pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

In this group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB.

Group Type ACTIVE_COMPARATOR

Regulating Mean Arterial Pressure during cardiopulmonary bypass

Intervention Type PROCEDURE

Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began.

2

In this group (High), the goal was to maintain MAP between 80-100 mm Hg during CPB.

Group Type EXPERIMENTAL

Regulating Mean Arterial Pressure during cardiopulmonary bypass

Intervention Type PROCEDURE

Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began.

Interventions

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Regulating Mean Arterial Pressure during cardiopulmonary bypass

Patients were randomized to one of two groups. In the first group (Low) the goal was to maintain MAP between 50-60 mm Hg during CPB. In the second group (High), the goal was to maintain MAP between 80-100 mm Hg. In both groups, CPB flow was held constant at 1.6 L/min/M2 (cool) and 2.4 L/min/M2 (warm) and vasoactive drugs (nitroglycerin or phenylephrine) were used to maintain MAP in the desired range. MAP was controlled in this fashion from the onset of CPB through separation from CPB began.

Intervention Type PROCEDURE

Other Intervention Names

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Mean Arterial Pressure during cardiopulmonary bypass 50-60 mm/Hg (control) vs. 80-100 mm/Hg (experimental)

Eligibility Criteria

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Inclusion Criteria

1. Patients had to be undergoing elective CABG, without concomitant valve or other cardiac surgery.
2. Patients also had to be able to perform the neuropsychologic tests, and to provide informed consent.

Exclusion Criteria

1. Patients who refused to participate in the study.
2. Patients who live too far away from NYC to be able to come back for follow up at six months post-operatively.
3. Patients who had either valvular replacement and aortic amd mitral an aneurysm repair, or other cardiothoracic surgery.
4. Patients who were unable to complete the neuropsychologic test.
5. Patient who were part of another CABG study.
Minimum Eligible Age

18 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

Locations

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New York Presbyterian Hospital-Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0001004169 (Formerly 0100-006)

Identifier Type: -

Identifier Source: org_study_id