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Influence of CPB Temperature on CABG Morbidity

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000604
Enrollment
Unknown
Registered
1999-10-28
Start date
1994-01-31
Completion date
1996-12-31
Last updated
2015-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Neurologic Manifestations

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.

Detailed description

BACKGROUND: 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. DESIGN NARRATIVE: 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.

Interventions

PROCEDUREcardiopulmonary bypass
PROCEDUREheart arrest, induced

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Baystate Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026