Aorta AneurysmClevidipineNCT01480531
Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection
A study testing Clevidipine in people with Aorta Aneurysm and Dissection of Aorta, run by Duke University at 1 site in United States.
Trial summary
2. Purpose of the Study - 1. To determine the feasibility of Clevidipine use for rapidly achieving and maintaining individually specified patient BP target ranges in the pre and postoperative periods of aortic aneurysm and dissection management. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aorta Aneurysm, Dissection of Aorta
- What is being tested?
- Clevidipine
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection.
- Purpose of the Study -
- To determine the feasibility of Clevidipine use for rapidly achieving and maintaining individually specified patient BP target ranges in the pre and postoperative periods of aortic aneurysm and dissection management.
- To determine the safety of Clevidipine use in the pre and postoperative periods of aneurysm and dissection management
- Background \& Significance - Surgical treatments for persons with aortic root/arch dissection or aneurysm have significantly improved survival. However, critical in management of these patients is precise control of blood pressure (BP). With increasing BP, both acute and chronic, the risk of fatal and nonfatal vascular complications is imminent. Similarly, with excessive lowering of arterial pressures, cerebral, spinal cord, cardiac, and renal ischemic hypoperfusion is also noteworthy. Typically, the target systolic blood pressure range for these patients is 100-120 mmHg. Several different classes of vasoactive agents are in current use to acutely manage BP but none possess the optimal profile of an ideal vasodilator. Notable limitations include inadequate potency, slow onset and offset of action, multiple receptor function, safety concerns and, importantly, restricted/ineffective titration, which results in clinically significant hemodynamic and cardiovascular perturbations. Recently, the ultra short-acting intravenous dihydropyridine calcium-channel blocker clevidipine (Cleviprex, The Medicines Company) was approved for management of BP in critical care settings. Clevidipine's pharmacology lends itself to acute management of BP in a broad critical care setting in both surgical and nonsurgical patients. In the current study, the investigators propose to further characterize the hemodynamic effect of CLV in the pre and post-operative management of BP in patients with aortic aneurysm/dissection.
- Design \& Procedures Eligible patients will be approached to participate in the study by the Intensive Care Unit (ICU) attending and/or by a cardiothoracic surgical/anesthesiology fellow or a cardiac research nurse. All aspects of clinical management and monitoring will be according to standard practice that includes:
- 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).
Read more
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
- Being tested
- Clevidipine
- Keywords
- aorta, aneurysm, dissection
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevidipineDrug
Also called Cleviprex
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Begining 24 hours prior to surgery thru 24 hours after surgery
Secondary outcomes (1)
The incidence of hypotension
To determine the safety of Clevidipine use in the pre and postoperative periods of aneurysm and dissection management to prevent hypotension as defined by a systolic blood pressure of less than 75 mm Hg.
Measured: Begining 24 hours prior to surgery thru 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: We elected to stop this study due to our inability to recruit suitable subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Aorta AneurysmStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Medicines Company
- Responsible party
- Sponsor
- Investigators
- Manuel Fontes, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480531
- Sponsor's protocol ID
- Pro00030060
- Acronym
- Clevidipine
- Status last verified
- Jan 2013
- First submitted
- 14 Oct 2011
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10206087Ericsson 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.
PubMed 10336577Bailey 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.
PubMed 11981147Pollack 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.
PubMed 18534716Aronson 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.
PubMed 18806012Aronson 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.
PubMed 11973166Reich 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.
PubMed 12145033Weiss 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.
PubMed 8261215Charlson 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.
PubMed 2241312Chobanian 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.
PubMed 14656957Vuylsteke 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.
PubMed 10890479Viljoen JF, Estafanous FG, Tarazi RC. Acute hypertension immediately after coronary artery surgery. J Thorac Cardiovasc Surg. 1976 Apr;71(4):548-50.
PubMed 817089Cheung 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.
PubMed 17578949Aronson 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.
PubMed 17283267
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre and or Post Operative Blood Pressure Control With Clevidipine (Cleviprexm Medicines Company) in Aortic Aneurysm / Dissection.
- ClinicalTrials.gov ID
- NCT01480531
- Acronym / sponsor ID
- Clevidipine / Pro00030060
- Conditions
- Aorta Aneurysm, Dissection of Aorta
- Keywords
- aorta, aneurysm, dissection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We elected to stop this study due to our inability to recruit suitable subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Medicines Company
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Purpose of the Study -
- To determine the feasibility of Clevidipine use for rapidly achieving and maintaining individually specified patient BP target ranges in the pre and postoperative periods of aortic aneurysm and dissection management.
- To determine the safety of Clevidipine use in the pre and postoperative periods of aneurysm and dissection management
- Background \& Significance - Surgical treatments for persons with aortic root/arch dissection or aneurysm have significantly improved survival. However, critical in management of these patients is precise control of blood pressure (BP). With increasing BP, both acute and chronic, the risk of fatal and nonfatal vascular complications is imminent. Similarly, with excessive lowering of arterial pressures, cerebral, spinal cord, cardiac, and renal ischemic hypoperfusion is also noteworthy. Typically, the target systolic blood pressure range for these patients is 100-120 mmHg. Several different classes of vasoactive agents are in current use to acutely manage BP but none possess the optimal profile of an ideal vasodilator. Notable limitations include inadequate potency, slow onset and offset of action, multiple receptor function, safety concerns and, importantly, restricted/ineffective titration, which results in clinically significant hemodynamic and cardiovascular perturbations. Recently, the ultra short-acting intravenous dihydropyridine calcium-channel blocker clevidipine (Cleviprex, The Medicines Company) was approved for management of BP in critical care settings. Clevidipine's pharmacology lends itself to acute management of BP in a broad critical care setting in both surgical and nonsurgical patients. In the current study, the investigators propose to further characterize the hemodynamic effect of CLV in the pre and post-operative management of BP in patients with aortic aneurysm/dissection.
- Design \& Procedures Eligible patients will be approached to participate in the study by the Intensive Care Unit (ICU) attending and/or by a cardiothoracic surgical/anesthesiology fellow or a cardiac research nurse. All aspects of clinical management and monitoring will be according to standard practice that includes:
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClevidipineAlso: CleviprexClevidipine 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) | Drug | – |
Primary outcome
The use of Clevidipine to maintain clinically acceptable blood pressure.
Time frame: Begining 24 hours prior to surgery thru 24 hours after surgery
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.
1 secondary outcome
The incidence of hypotension
Time frame: Begining 24 hours prior to surgery thru 24 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
- Background: PubMed 10206087Ericsson 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.
- Background: PubMed 10336577Ericsson 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.
- Background: PubMed 11981147Bailey 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.
- Background: PubMed 18534716Pollack 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.
- Background: PubMed 18806012Aronson 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.
- Background: PubMed 11973166Aronson 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.
- Background: PubMed 12145033Reich 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.
- Background: PubMed 8261215Weiss 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.
- Background: PubMed 2241312Charlson 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.
- Background: PubMed 14656957Chobanian 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.
- Background: PubMed 10890479Vuylsteke 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.
- Background: PubMed 817089Viljoen JF, Estafanous FG, Tarazi RC. Acute hypertension immediately after coronary artery surgery. J Thorac Cardiovasc Surg. 1976 Apr;71(4):548-50.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Fontes, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clevidipine in people with Aorta Aneurysm and Dissection of Aorta, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The use of Clevidipine to maintain clinically acceptable blood pressure. (time frame: Begining 24 hours prior to surgery thru 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01480531, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.