Improving Outcomes and Quality of Life After CABG
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 17, 2005 | ||||||||
| Last Updated Date | March 31, 2008 | ||||||||
| Start Date ICMJE | December 1996 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00256620 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Improving Outcomes and Quality of Life After CABG | ||||||||
| Official Title ICMJE | Improving Outcomes and Quality of Life After CABG | ||||||||
| Brief Summary | The principal objective to this randomized trial is to compare the efficacy of two strategies of intra-operative hemodynamic management during cardiopulmonary bypass among patients undergoing primary elective coronary artery bypass graft (CABG) surgery in preventing peri-operative cardiac, cognitive and neurologic morbidity and mortality and post-operative deterioration in the patient's quality of life as measured by the seven domains of SF-36 Health Survey (bodily pain, health perceptions, energy, and mental, physical, social and role function). |
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| Detailed Description | In one group, mean arterial pressure (MAP) was 65 mmHg. In the other, the MAP target was determined by the patients usual preoperative MAP. Thus, the trial will evaluate whether tailoring the MAP target for the period of cardiopulmonary bypass to within 10 mmHg of the patients usual MAP, but < 90 mmHg (and thus achieving pressures during bypass within the patients usual autoregulatory range) reduces major neurologic and cardiac morbidity and mortality, as well as cognitive complications, thereby improving post-operative quality of life. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | |||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind Primary Purpose: Prevention |
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| Condition ICMJE | Coronary Artery Bypass Graft Surgery Patients | ||||||||
| Intervention ICMJE | Procedure: Mean arterial pressure during cardiopulmonary bypass 80 mmHg vs. customized | ||||||||
| Study Arm (s) | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 412 | ||||||||
| Completion Date | December 1999 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years to 89 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00256620 | ||||||||
| Other Study ID Numbers ICMJE | 9407000398 Formerly 0794-502CR | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Mary E. Charlson, MD, Weill Cornell Medical College | ||||||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||||||
| Verification Date | March 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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