- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000604
Influence of CPB Temperature on CABG Morbidity
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Engelman RM, Pleet AB, Rousou JA, Flack JE 3rd, Deaton DW, Kulshrestha P, Gregory CA, Pekow PS. Does cardiopulmonary bypass temperature correlate with postoperative central nervous system dysfunction? J Card Surg. 1995 Jul;10(4 Suppl):493-7. doi: 10.1111/j.1540-8191.1995.tb00683.x.
- Engelman RM, Pleet AB, Rousou JA, Flack JE 3rd, Deaton DW, Gregory CA, Pekow PS. What is the best perfusion temperature for coronary revascularization? J Thorac Cardiovasc Surg. 1996 Dec;112(6):1622-32; discussion 1632-3. doi: 10.1016/S0022-5223(96)70021-1.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108
- R01HL048631 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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