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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
  Purpose

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.


Condition Intervention Phase
Hypertension
Brain Tumor
Epilepsy
Drug: Clevidipine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clevidipine,brain tumor,hypertension
21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952081

Locations
United States, New York
NYU Langone Medical Center, Department of Anesthesiology
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
The Medicines Company
Investigators
Principal Investigator: Alex Bekker, MD, PhD NYU School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00952081     History of Changes
Other Study ID Numbers: 08-745
Study First Received: July 29, 2009
Results First Received: June 22, 2012
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Hypertension
Neurosurgery
bloodpressure control
brain tumor resection
epilepsy focus resection

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Epilepsy
Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014