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

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Hypertension; Brain Tumor; Epilepsy
Intervention:	Drug: Clevidipine

  Participant Flow

  Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients scheduled for intracranial surgery were prospectively enrolled after giving consent. Clevidipine (0.5 mg/mL in 20% lipid solution, which was to be initiated at 10 mg/h and titrated to effect) was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Clevidipine,Brain Tumor,Hypertension	Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.

Participant Flow:   Overall Study

	Clevidipine,Brain Tumor,Hypertension
STARTED	22
COMPLETED	22
NOT COMPLETED	0

  Baseline Characteristics

  Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

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

Baseline Measures

	Clevidipine,Brain Tumor,Hypertension
Overall Participants Analyzed; [Units: Participants]	22
Age; [Units: Participants]
<=18 years	0
Between 18 and 65 years	21
>=65 years	1
Age; [Units: Years]; Mean (Standard Deviation)	54 (14.25)
Gender; [Units: Participants]
Female	12
Male	10
Region of Enrollment; [Units: Participants]
United States	22

  Outcome Measures

1. Primary:

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 ]

  Show Outcome Measure 1

  Serious Adverse Events

  Show Serious Adverse Events

  Other Adverse Events

  Show Other Adverse Events

  Limitations and Caveats

  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

  Hide More Information

Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Alex Bekker, MD, PhD
Organization: UMDNJ
phone: 973-972-5007
e-mail: bekkeray@umdnj.edu

Responsible Party:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00952081 History of Changes
Other Study ID Numbers:	08-745
First Submitted:	July 29, 2009
First Posted:	August 4, 2009
Results First Submitted:	June 22, 2012
Results First Posted:	October 30, 2013
Last Update Posted:	February 9, 2015