Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection

NCT01480531 | Withdrawn

• 1 other identifier: Pro00030060
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

2\. Purpose of the Study -

• ECG
• Oxymetry
• Temperature
• Invasive arterial blood pressure
• Recording of routine laboratory results
• Imaging studies including CT/MRI (A)/ Echocardiography
• Pulmonary artery catheter (postoperative patients)
• Mechanical ventilation (postoperative patients)
• According to established protocol for acute intravenous management of arterial blood pressure in these patients, an upper and lower threshold of systolic blood pressure will be prescribed by the attending physician (the range being (100 mmHg -120 mm Hg SBP). Hemodynamic data will be collected continuously via a bedside laptop as well as pertinent clinical data and information about efficacy and safety will be recorded.
• Subjective evaluation of efficacy of CLV (questionnaire format to be completed by the critical care team)

Conditions

Aorta Aneurysm; Dissection of Aorta

Keywords

aorta; aneurysm; dissection

Outcome Measures

Primary Outcomes (1)

• The use of Clevidipine to maintain clinically acceptable blood pressure.

  To determine the feasibility of Clevidipine use for rapidly achieving and maintaining individually specified patient BP target ranges (75 to 135 mm Hg) in the pre and postoperative periods of aortic aneurysm and dissection management.

  Begining 24 hours prior to surgery thru 24 hours after surgery

Secondary Outcomes (1)

• The incidence of hypotension

  Begining 24 hours prior to surgery thru 24 hours after surgery

Interventions

Clevidipine DRUG

Clevidipine administration begins in the ER or ICU * Clevidipine is again administered post op when blood pressure control is required. * Clevidipine will be administered by an infusion pump via either a central line or a peripheral IV as follows: * Clevidipine will be initiated at an infusion rate of 0.4 μg•kg-1•min-1 and will be titrated as tolerated in doubling increments every 90 s up to 3.2 μg•kg-1•min-1. * Infusion rates above 3.2 μg•kg-1•min-1 will be guided by the patient's response and permitted in serial increments of 1.5 μg•kg-1•min-1. * Infusion rates between 4.4 and 8.0 μg•kg-1•min-1 will be administered for no longer than 2 h. As blood pressure approaches goal, increase dose by less than double and lengthen time between does adjustments to every 5-10 minutes (a 1-2 mg/hr increase will generally result in a 2-4 mm Hg reduction in SBP)

Also known as: Cleviprex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age 18-80 years)
• Able to provide written consent
• Type I and Type II (Type A) aortic dissection or unstable chronic aortic aneurysm
• Patients expected to be admitted to ICU following aortic surgery for either dissection or aneurysm requiring acute management of elevated systolic blood pressure (consent obtained preoperatively)

You may not qualify if:

• Unstable emergent dissections
• Evidence of end-organ dysfunction (ischemia of spinal cord, bowel, myocardium or renal)
• Active bleeding
• Allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis
• Women who are pregnant
• Female subjects of child bearing potential must have a blood serum pregnancy test performed prior to participating in this study and the results must be negative.

Sponsors & Collaborators

• Duke University: lead
• The Medicines Company: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (14)

• Ericsson H, Fakt C, Hoglund L, Jolin-Mellgard A, Nordlander M, Sunzel M, Regardh CG. Pharmacokinetics and pharmacodynamics of clevidipine in healthy volunteers after intravenous infusion. Eur J Clin Pharmacol. 1999 Mar;55(1):61-7. doi: 10.1007/s002280050594.

  PMID: 10206087 BACKGROUND

• Ericsson H, Fakt C, Jolin-Mellgard A, Nordlander M, Sohtell L, Sunzel M, Regardh 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. doi: 10.1046/j.1365-2125.1999.00933.x.

  PMID: 10336577 BACKGROUND

• 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. doi: 10.1097/00000542-200205000-00010.

  PMID: 11981147 BACKGROUND

• 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.

  PMID: 18534716 BACKGROUND

• 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.

  PMID: 18806012 BACKGROUND

• 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. doi: 10.1097/00000539-200205000-00005.

  PMID: 11973166 BACKGROUND

• 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. doi: 10.1097/00000539-200208000-00003.

  PMID: 12145033 BACKGROUND

• Weiss SJ, Longnecker DE. Perioperative hypertension: an overview. Coron Artery Dis. 1993 May;4(5):401-6. doi: 10.1097/00019501-199305000-00002. No abstract available.

  PMID: 8261215 BACKGROUND

• 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. doi: 10.1097/00000658-199011000-00003.

  PMID: 2241312 BACKGROUND

• 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. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1.

  PMID: 14656957 BACKGROUND

• Vuylsteke A, Feneck RO, Jolin-Mellgard A, Latimer RD, Levy JH, Lynch C 3rd, Nordlander ML, Nystrom 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.

  PMID: 10890479 BACKGROUND

• Viljoen JF, Estafanous FG, Tarazi RC. Acute hypertension immediately after coronary artery surgery. J Thorac Cardiovasc Surg. 1976 Apr;71(4):548-50.

  PMID: 817089 BACKGROUND

• 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. doi: 10.1213/01.ane.0000264078.34514.32.

  PMID: 17578949 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.106.623538. Epub 2007 Feb 5.

  PMID: 17283267 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Dissection; Aneurysm

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Manuel Fontes, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: November 29, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 11, 2013

Record last verified: 2013-01

Locations

US (1)