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Improving Outcomes and Quality of Life After CABG

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Completed

Conditions

Coronary Artery Bypass Graft Surgery Patients

Treatments

Procedure: Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00256620
9407000398 Formerly 0794-502CR

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

35 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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