Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000604
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
1999-10-27
Brief Title:
Influence of CPB Temperature on CABG Morbidity
Sponsor:
Baystate Medical Center
Organization:
Baystate Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 375 percent warm versus 75 percent cold P less than 005 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
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 375 percent warm versus 75 percent cold P less than 005 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL048631 | NIH | None | httpsreporternihgovquickSearchR01HL048631 |