Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005690
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Improving Outcomes and Quality of Life After CABG
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-01
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:
Among patients undergoing elective primary coronary artery bypass graft CABG the principal objective of this randomized trial was to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass in preventing peri-operative cardiac cognitive and neurologic morbidity and mortality and post-operative deterioration in patients quality of life as measured by the SF-36
Detailed Description:
BACKGROUND
Surgical myocardial revascularization CABG is an effective treatment for triple vessel and left main coronary artery disease used for thousands of patients annually in the United States CABG certainly prolongs life and data demonstrates that it improves functional status for the majority of patients The intervention in this trial is based upon the outcomes of the investigators first trial which showed a benefit to maintaining mean intra-bypass mean arterial pressure MAP at 65 mm Hg in the high MAP group vs 52 mm Hg in the low MAP group Intra-bypass MAPs corrected for intervals less than full flow were 81 mm Hg for the high group and 59 mm Hg for the low MAP group Cardiac and neurologic morbidity and mortality were 48 percent in the high MAP group versus 129 percent in the low MAP group p026 All adverse outcomes were lower in the high MAP group 161 percent than in the low MAP group 274 percent Data from the previous study also suggests that outcomes may be further improved by maintaining intra-bypass MAP close to the patients preoperative MAP This is consistent with the investigators previous work in non-cardiac surgery which shows that maintaining MAP within patients usual autoregulatory range is associated with lower cardiac and renal complication rates This study will determine whether refining the approach to hemodynamic management will further improve patient outcomes after coronary revascularization
DESIGN NARRATIVE
The First Clinical Study
During the first three years of grant support from August 1991 to November 1995 clinical research was conducted on a comparison of intraoperative high versus low mean arterial pressure MAP on outcomes after coronary artery bypass In this study 248 patients undergoing primary nonemergency coronary bypass were randomized to either low n 124 or high n 124 mean arterial pressure during cardiopulmonary bypass The impact of the mean arterial pressure strategies on the following outcomes was assessed mortality cardiac morbidity neurologic morbidity cognitive deterioration and changes in quality of life All patients were observed prospectively to six months after the operation Results are described under the Results Section
Second Clinical Study
The second clinical study under grant R01HL44719 began in December 1995 and was a prospective trial of 412 patients who were evaluated pre-operatively monitored intra-operatively and followed post-operatively according to a standardized surveillance protocol Patients were randomized to two forms of hemodynamic management during cardiopulmonary bypass In one group the intra-operative mean arterial pressure MAP during bypass was maintained at 65 mm Hg or 81 mm Hg at full flow thus employing the most effective strategy from the investigators first trial In the second group the intra-operative MAP was maintained at their pre-operative MAP but below 90 mm Hg a strategy supported by data from the first trial The principal outcome was the occurrence of any one of the following mortality at six months major cardiopulmonary morbidity ie myocardial infarction pulmonary edema cardiogenic shock or low flow state cognitive complications defined by a summary definition which included improvement and decline on neuropsychologic tests of memory psychomotorattention and linguistic function major neurologic complications ie new focal deficits such as hemiplegia aphasia cortical blindness and significant deterioration in functional status at six months postoperatively The long term objective was to preserve and further improve the quality of life after CABG
Although the study was described as a clinical trial the Behavioral Medicine Study Section defined it as clinical research not a NIH-defined Phase III trial
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Surgical myocardial revascularization CABG is an effective treatment for triple vessel and left main coronary artery disease used for thousands of patients annually in the United States CABG certainly prolongs life and data demonstrates that it improves functional status for the majority of patients The intervention in this trial is based upon the outcomes of the investigators first trial which showed a benefit to maintaining mean intra-bypass mean arterial pressure MAP at 65 mm Hg in the high MAP group vs 52 mm Hg in the low MAP group Intra-bypass MAPs corrected for intervals less than full flow were 81 mm Hg for the high group and 59 mm Hg for the low MAP group Cardiac and neurologic morbidity and mortality were 48 percent in the high MAP group versus 129 percent in the low MAP group p026 All adverse outcomes were lower in the high MAP group 161 percent than in the low MAP group 274 percent Data from the previous study also suggests that outcomes may be further improved by maintaining intra-bypass MAP close to the patients preoperative MAP This is consistent with the investigators previous work in non-cardiac surgery which shows that maintaining MAP within patients usual autoregulatory range is associated with lower cardiac and renal complication rates This study will determine whether refining the approach to hemodynamic management will further improve patient outcomes after coronary revascularization
DESIGN NARRATIVE
The First Clinical Study
During the first three years of grant support from August 1991 to November 1995 clinical research was conducted on a comparison of intraoperative high versus low mean arterial pressure MAP on outcomes after coronary artery bypass In this study 248 patients undergoing primary nonemergency coronary bypass were randomized to either low n 124 or high n 124 mean arterial pressure during cardiopulmonary bypass The impact of the mean arterial pressure strategies on the following outcomes was assessed mortality cardiac morbidity neurologic morbidity cognitive deterioration and changes in quality of life All patients were observed prospectively to six months after the operation Results are described under the Results Section
Second Clinical Study
The second clinical study under grant R01HL44719 began in December 1995 and was a prospective trial of 412 patients who were evaluated pre-operatively monitored intra-operatively and followed post-operatively according to a standardized surveillance protocol Patients were randomized to two forms of hemodynamic management during cardiopulmonary bypass In one group the intra-operative mean arterial pressure MAP during bypass was maintained at 65 mm Hg or 81 mm Hg at full flow thus employing the most effective strategy from the investigators first trial In the second group the intra-operative MAP was maintained at their pre-operative MAP but below 90 mm Hg a strategy supported by data from the first trial The principal outcome was the occurrence of any one of the following mortality at six months major cardiopulmonary morbidity ie myocardial infarction pulmonary edema cardiogenic shock or low flow state cognitive complications defined by a summary definition which included improvement and decline on neuropsychologic tests of memory psychomotorattention and linguistic function major neurologic complications ie new focal deficits such as hemiplegia aphasia cortical blindness and significant deterioration in functional status at six months postoperatively The long term objective was to preserve and further improve the quality of life after CABG
Although the study was described as a clinical trial the Behavioral Medicine Study Section defined it as clinical research not a NIH-defined Phase III trial
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 |
|---|---|---|---|
| R01HL044719 | NIH | None | httpsreporternihgovquickSearchR01HL044719 |