Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection (Clevidipine)
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|ClinicalTrials.gov Identifier: NCT01480531|
Recruitment Status : Withdrawn (We elected to stop this study due to our inability to recruit suitable subjects.)
First Posted : November 29, 2011
Last Update Posted : February 11, 2013
The Medicines Company
Information provided by (Responsible Party):
No Study Results Posted on ClinicalTrials.gov for this Study
Study was withdrawn before participants were enrolled.
|Recruitment Status :||Withdrawn|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Ericsson H, Fakt C, Höglund L, Jolin-Mellgård A, Nordlander M, Sunzel M, Regårdh CG. Pharmacokinetics and pharmacodynamics of clevidipine in healthy volunteers after intravenous infusion. Eur J Clin Pharmacol. 1999 Mar;55(1):61-7.
Ericsson H, Fakt C, Jolin-Mellgård A, Nordlander M, Sohtell L, Sunzel M, Regårdh CG. Clinical and pharmacokinetic results with a new ultrashort-acting calcium antagonist, clevidipine, following gradually increasing intravenous doses to healthy volunteers. Br J Clin Pharmacol. 1999 May;47(5):531-8.
Bailey JM, Lu W, Levy JH, Ramsay JG, Shore-Lesserson L, Prielipp RC, Brister NW, Roach GW, Jolin-Mellgard A, Nordlander M. Clevidipine in adult cardiac surgical patients: a dose-finding study. Anesthesiology. 2002 May;96(5):1086-94.
Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF 4th. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2009 Mar;53(3):329-38. doi: 10.1016/j.annemergmed.2008.04.025. Epub 2008 Jun 5.
Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.
Aronson S, Boisvert D, Lapp W. Isolated systolic hypertension is associated with adverse outcomes from coronary artery bypass grafting surgery. Anesth Analg. 2002 May;94(5):1079-84, table of contents.
Reich DL, Bennett-Guerrero E, Bodian CA, Hossain S, Winfree W, Krol M. Intraoperative tachycardia and hypertension are independently associated with adverse outcome in noncardiac surgery of long duration. Anesth Analg. 2002 Aug;95(2):273-7, table of contents.
Weiss SJ, Longnecker DE. Perioperative hypertension: an overview. Coron Artery Dis. 1993 May;4(5):401-6. Review.
Charlson ME, MacKenzie CR, Gold JP, Ales KL, Topkins M, Shires GT. Intraoperative blood pressure. What patterns identify patients at risk for postoperative complications? Ann Surg. 1990 Nov;212(5):567-80.
Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52. Epub 2003 Dec 1.
Vuylsteke A, Feneck RO, Jolin-Mellgård A, Latimer RD, Levy JH, Lynch C 3rd, Nordlander ML, Nyström P, Ricksten SE. Perioperative blood pressure control: a prospective survey of patient management in cardiac surgery. J Cardiothorac Vasc Anesth. 2000 Jun;14(3):269-73.
Viljoen JF, Estafanous FG, Tarazi RC. Acute hypertension immediately after coronary artery surgery. J Thorac Cardiovasc Surg. 1976 Apr;71(4):548-50.
Cheung AT, Cruz-Shiavone GE, Meng QC, Pochettino A, Augoustides JA, Bavaria JE, Ochroch EA. Cardiopulmonary bypass, hemolysis, and nitroprusside-induced cyanide production. Anesth Analg. 2007 Jul;105(1):29-33.
Aronson S, Fontes ML, Miao Y, Mangano DT; Investigators of the Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. Risk index for perioperative renal dysfunction/failure: critical dependence on pulse pressure hypertension. Circulation. 2007 Feb 13;115(6):733-42. Epub 2007 Feb 5.