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

NCT00952081 | Completed Phase 4 Results DMC

• 1 other identifier: 08-745
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Brain Tumor; Epilepsy

Keywords

Hypertension; Neurosurgery; bloodpressure control; brain tumor resection; epilepsy focus resection

Outcome Measures

Primary Outcomes (1)

• 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)

  intraoperatively and 90 min after surgery

Study Arms (1)

clevidipine,brain tumor,hypertension

EXPERIMENTAL

21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia

Drug: Clevidipine

Interventions

Clevidipine DRUG

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.

Also known as: Cleviprex, Clevidipine butyrate

clevidipine,brain tumor,hypertension

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• The Medicines Company: collaborator

Study Sites (1)

NYU Langone Medical Center, Department of Anesthesiology

New York, New York, 10016, United States

Location

Related Links

• pubmed abstract

MeSH Terms

Conditions

Hypertension; Brain Neoplasms; Epilepsy

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Alex Bekker, MD, PhD
• Organization: UMDNJ

bekkeray@umdnj.edu

973-972-5007

Study Officials

• Alex Bekker, MD, PhD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: February 9, 2015
• Results First Posted: October 30, 2013

Record last verified: 2015-01

Locations

US (1)