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CompletedNCT00248885Updated Apr 11, 2008

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

An interventional study of Regulating Mean Arterial Pressure during cardiopulmonary bypass in Coronary Artery Bypass Graft Surgery, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-11.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Coronary Artery Bypass Graft Surgery

Keywords

  • Coronary artery bypass graft surgery
  • Perioperative complications
  • Neurocognitive function
  • Quality of life
  • Blood pressure
03

In context

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 163 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
248 participants (actual)

Study arms

  • Active comparator
    1

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

    Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass

  • Experimental
    2

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

    Procedure: Regulating Mean Arterial Pressure during cardiopulmonary bypass

Interventions

  • ProcedureRegulating 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.

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

06

What researchers measure

Primary outcomes

  1. Cardiac morbidity

    Time frame: 6-months after surgery

  2. Neurologic morbidity

    Time frame: 6-months after surgery

  3. Mortality

    Time frame: 6-months after surgery

  4. Functional status

    Time frame: 6-months after surgery

  5. Neurocognitive function

    Time frame: 6-months after surgery

07

Study locations

1 site
  • New York Presbyterian Hospital-Weill Cornell Medical College
    New York, New York 10065, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00248885
First posted
Nov 4, 2005
Start date
Sep 1991
Completion
Sep 1994
Last update
Apr 11, 2008

Study contacts

Mary E Charlson, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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