Improving Outcomes and Quality of Life After CABG

Weill Medical College of Cornell University412 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

412

Conditions

Coronary Artery Bypass Graft Surgery Patients

Interventions

Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customizedPROCEDURE

Eligibility

Sex: ALLMin age: 35 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

New York Presbyterian Hospital-Weill Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Quality of life

Cardiac morbidity

Neurologic morbidity

Mortality

Neurocognitive deterioration

Secondary Outcomes

• 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.