Clinical trial NCT00256620: Improving Outcomes and Quality of Life After CABG
Official title: Improving Outcomes and Quality of Life After CABG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft Surgery Patients
Keywords: Cardiopulmonary bypass
Coronary artery disease
Cardiac morbidity
Neurologic morbidity
Neurocognitive function
Autoregulation
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-11-21
Enrollment: 412
Sex: ALL
Minimum age (years): 35
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
measure: Cardiac morbidity
measure: Neurologic morbidity
measure: Mortality
measure: Neurocognitive deterioration
Secondary outcomes:
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.
measure: • To correlate TEE and epiaortic scanning for aortic atheroma with transthoracic echocardiography (TTE) in order to develop a non-invasive screening tool.
measure: • 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
measure: • To provide data on the mechanism of perioperative neurologic and cognitive complications in order to design other specific intervention to reduce postoperative morbidity.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Karl Krieger, MD
role: PRINCIPAL_INVESTIGATOR
References: