Clevidipine compared with nitroglycerin for blood pressure control in coronary artery bypass grafting: a randomized double-blind study
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- 作者：Alan F. Merry MBChB (1) (2) (7)
Edwin G. Avery MD (3) (8)
Nancy A. Nussmeier MD (4) (9)
Hugh R. Playford MBBS (10) (5)
Guy R. Warman PhD (1)
Yamei Wang MS (6)
Robert N. Sladen MBChB (5) - 刊名：Canadian Journal of Anesthesia/Journal canadien d'anesth篓娄sie
- 出版年：2014
- 出版时间：May 2014
- 年：2014
- 卷：61
- 期：5
- 页码：398-406
- 全文大小：449 KB
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Edwin G. Avery MD (3) (8)
Nancy A. Nussmeier MD (4) (9)
Hugh R. Playford MBBS (10) (5)
Guy R. Warman PhD (1)
Yamei Wang MS (6)
Robert N. Sladen MBChB (5)
1. Faculty of Medical and Health Sciences, School of Medicine, The University of Auckland, Private Bag 92019, Auckland, 1003, New Zealand
2. Green Lane Hospital and Mercy Ascot Integrated Hospital, Auckland, New Zealand
7. Auckland City Hospital, Auckland, New Zealand
3. Massachusetts General Hospital, Boston, MA, USA
8. University Hospitals Case Medical Center, Cleveland, OH, USA
4. Texas Heart Institute, Houston, TX, USA
9. Massachusetts General Hospital, Boston, MA, USA
10. Westmead Hospital, Sydney, Australia
5. College of Physicians and Surgeons of Columbia University, New York, NY, USA
6. The Medicines Company, Parsippany, NJ, USA - ISSN：1496-8975
文摘
Purpose We tested the hypothesis that clevidipine, a rapidly acting dihydropyridine calcium channel blocker, is not inferior to nitroglycerin (NTG) in controlling blood pressure before cardiopulmonary bypass (CPB) during coronary artery bypass grafting (CABG). Methods In this double-blind study from October 4, 2003 to April 26, 2004, 100 patients undergoing CABG with CPB were randomized at four centres to receive intravenous infusions of clevidipine (0.2-8?μg·kg?·min?) or NTG (0.4?μg·kg?·min? to a clinician-determined maximum dose rate) from induction of anesthesia through 12?hr postoperatively. The study drug was titrated in the pre-CPB period with the aim of maintaining mean arterial pressure (MAP) within ±?5?mmHg of a clinician-predetermined target. The primary endpoint was the area under the curve (AUC) for the total time each patient’s MAP was outside the target range from drug initiation to the start of CPB, normalized per hour (AUCMAP-D). The predefined non-inferiority criterion for the primary endpoint was a 95% confidence interval (CI) upper limit no greater than 1.50 for the geometric means ratio between clevidipine and NTG. Results Total mean [standard deviation (SD)] dose pre-bypass was 4.5 (4.7)?mg for clevidipine and 6.9 (5.4)?mg for NTG (P?<?0.05). The geometric mean AUCMAP-D for clevidipine was 283?mmHg·min·hr? (n?=?45) and for NTG was 292?mmHg·min·hr? (n?=?48); the geometric means ratio was 0.97 (95% CI 0.74 to 1.27). The geometric mean AUCMAP-D during aortic cannulation was 357.7?mmHg·min·hr? for clevidipine compared with 190.5?mmHg·min·hr? for NTG. Mean (SD) heart rate with clevidipine was 76.0 (13.8) beats·min? compared with 81.5 (14.4) beats·min? for NTG. There were no clinically important differences between groups in adverse events. Conclusion During CABG, clevidipine was not inferior to NTG for blood pressure control pre-bypass.