Influence of CPB Temperature on CABG Morbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000604
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : December 14, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Baystate Medical Center

Brief Summary:
To compare three accepted modes of myocardial preservation, warm, tepid, and cold blood cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (CPB) to define differences in neurologic function in coronary artery bypass graft (CABG) patients.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Procedure: cardiopulmonary bypass Procedure: heart arrest, induced Phase 2

Detailed Description:


A pilot study of warm versus cold perfusion and preservation was completed in 32 patients prior to the ongoing study. The findings of the pilot study showed 53 percent of patients had evidence of new neurologic disturbance at postoperative day four. Only the neurologic dysfunction could be correlated with warm versus cold perfusion (37.5 percent warm versus 75 percent cold, P less than 0.05). The changes in neurologic function had abated or clearly improved by one month of follow-up, and the distinction in neurologic dysfunction grading was no longer apparent between the two groups.


Patients were randomly assigned to cold, tepid, or warm blood cardioplegia, coinciding with normothermic, tepid, and hypothermic cardiopulmonary bypass. All patients received a standard anesthetic protocol combining narcotic and inhalational anesthesia. Each patient entering the study had extensive clinical data collected prospectively incorporating most aspects of measurable determinants related to myocardial preservation. Additionally, neurologic tests were performed by a blinded neurologist and rated by an objective scoring system, the Mathew scale. The studies were performed preoperatively, on the third or fourth postoperative day, and at one month following surgery. Hematologic data were measured for fibrinolytic potential.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : January 1994
Study Completion Date : December 1996

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Patients, referred for elective or urgent coronary revascularization, not having ongoing angina instability, requiring three or more bypass grafts, and under 70 years of age.

Publications: Identifier: NCT00000604     History of Changes
Other Study ID Numbers: 108
R01HL048631 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Neurologic Manifestations
Pathologic Processes
Vascular Diseases
Arterial Occlusive Diseases
Nervous System Diseases
Signs and Symptoms