A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients

This study has been completed.
Sponsor:
Collaborator:
The Medicines Company
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00952081
First received: July 29, 2009
Last updated: November 18, 2013
Last verified: November 2013

July 29, 2009
November 18, 2013
July 2009
December 2009   (final data collection date for primary outcome measure)
The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control) [ Time Frame: intraoperatively and 90 min after surgery ] [ Designated as safety issue: No ]
The primary endpoint of this trial is the proportion of patients who did not require rescue antihypertensive medication to maintain SBP below 130 mmHg (i.e. clevidipine is a sole antihypertensive agent used for blood pressure control) [ Time Frame: intraoperatively and 60 min after surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952081 on ClinicalTrials.gov Archive Site
Not Provided
  • The time that is required to reduce systolic blood pressure below 130 mmHg during surgery as well as during recovery period [ Time Frame: intraoperatively and 90 min after surgery ] [ Designated as safety issue: No ]
  • The dosages of clevidipine required to achieve goal of maintaining systolic blood pressure below 130 mmHg [ Time Frame: intraoperatively and 60 min after surgery ] [ Designated as safety issue: No ]
  • The perioperative use of antihypertensive and vasoactive drugs (for hypertension that is not responded to clevidipine) [ Time Frame: intraoperatively and in PACU ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients
A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients

This protocol describes a study to gain experience in the use of Clevidipine for perioperative blood pressure control in patients undergoing craniotomy for brain tumor or epilepsy focus resection. The purpose of this study is to establish the efficacy of Clevidipine for intraoperative blood pressure control in patients undergoing intracranial procedures, and gather information on the dosage and adverse effects of Clevidipine in neurosurgical patients. This initial pilot experience serves to familiarize the investigators with the use of this drug prior to initiating a planned randomized trial versus institutional standard-of-care therapy. The investigators will obtain greater familiarity with the dosing of clevidipine in this patient population and collect information on the incidence of adverse effects.

Clevidipine, a recently introduced, short-acting, vascular-selective calcium antagonist, could be a potentially useful adjuvant for neurosurgical cases. It decreases arterial blood pressure by reducing systemic vascular resistance with no effect on venous capacitance vessels (7). Clevidipine was successfully used for the treatment of hypertension in cardiac surgical patients (8). However, there is no information available on its efficacy and safety in patients undergoing intracranial surgery.

The perioperative course of patients undergoing intracranial surgery is frequently complicated by acute hypertensive episodes. Acute hypertension in neurosurgical patients is associated with intracranial bleeds and prolonged hospital stay (1). Even with current neuroanesthesia management, hemodynamic stability may be challenging, especially in hypertensive patients. An anesthetic technique that improves perioperative hemodynamics without increasing the incidence of undesirable events (such as increased intracranial pressure, prolonged recovery, etc.) is desirable.

A number of antihypertensive agents are available to treat perioperative hypertension. Labetalol is commonly used to treat hypertensive episodes in patients undergoing craniotomy, but may not be desirable in certain patient populations because of its low potency, a slow onset of peak effect (2), and unpredictability in dose requirements (3). Esmolol is only mildly effective in treating postoperative hypertension. Perioperative use is further complicated by bradycardia and conduction delay. Nicardipine is more effective than esmolol in controlling postoperative hypertension (4). However, it causes a dose-dependent cerebral vasodilation, inhibition of autoregulation, as well as a high incidence of hypotension (as compared to labetalol) (5). Hydralazine may increase intracranial pressure by as much as 100% and is rarely used as the sole agent in treating hypertension in neurosurgical patients (6).

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Brain Tumor
  • Epilepsy
Drug: Clevidipine
Clevidipine (0.5 mg/ml in 20 % lipid solution) will be administered via peripheral vein using syringe pump; drug infusion will be initiated at 5 mg/hr (10ml/h) and titrated to effect up to a maximum rate of 32 mg/hr when SBP exceeds 130 mm Hg. The anesthesiologist will be allowed to administer the alternative antihypertensive treatment (e.g. labetalol, hydralazine) after achieving a maximum clevidipine infusion rate.
Other Names:
  • Clevidipine
  • Cleviprex
  • Clevidipine butyrate
Experimental: clevidipine,brain tumor,hypertension
21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
Intervention: Drug: Clevidipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
February 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 21 or older
  • Able to give consent
  • No significant laboratory abnormalities
  • Undergoing elective surgery for tumor resection or epilepsy focus resection

Exclusion Criteria:

  • Patients with acute cardiac ischemia, renal or liver dysfunction, unstable hemodynamic, advanced heart block, or pregnancy defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis will be excluded.
  • Known or suspected allergy to study drug or study drug components,patients with allergies to soybeans, soy products, eggs, or egg products; Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment in this study.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952081
08-745
Yes
New York University School of Medicine
New York University School of Medicine
The Medicines Company
Principal Investigator: Alex Bekker, MD, PhD NYU School of Medicine
New York University School of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP