Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion (PrePARE)

This study has been completed.

Sponsor:

Collaborator:

Hospira, Inc.

Information provided by (Responsible Party):

Carmelo Graffagnino, Duke University Medical Center

ClinicalTrials.gov Identifier:

NCT00538616

First received: September 28, 2007

Last updated: March 1, 2013

Last verified: March 2013

History of Changes

Results First Received: December 12, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Conditions:	Brain Injury Intracranial Pressure
Interventions:	Drug: Dexmedetomidine Drug: Propofol

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
Subjects approached if they had indwelling Licox catheters and were given sedation.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study started at onset of shift with 1 hour washout between crossover. One subject taken off sedation prior to enrollment because they were no longer eligible

Reporting Groups

	Description
Precedex-Propofol	Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
Propofol- Precedex	Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.

Participant Flow: Overall Study

	Precedex-Propofol	Propofol- Precedex
STARTED	5	3
COMPLETED	5	3
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Precedex-Propofol	Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
Propofol- Precedex	Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
Total	Total of all reporting groups

Baseline Measures

	Precedex-Propofol	Propofol- Precedex	Total
Number of Participants [units: participants]	5	3	8
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	5	2	7
>=65 years	0	1	1
Age [units: years] Mean ± Standard Deviation	33 ± 5.6	55 ± 8.6	41.5 ± 6.0
Gender [units: participants]
Female	0	1	1
Male	5	2	7
Region of Enrollment [units: participants]
United States	5	3	8

Outcome Measures

1. Primary:

Lactate/Pyruvate (L/P)Ratio [ Time Frame: 1 hour ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

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.

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.

Results Point of Contact:

Name/Title: Dr. Carmelo Graffagnino
Organization: Duke University
phone: 919/681-3751
e-mail: Carmelo.Graffagnino@duke.edu

No publications provided

Responsible Party:	Carmelo Graffagnino, Duke University Medical Center
ClinicalTrials.gov Identifier:	NCT00538616 History of Changes
Other Study ID Numbers:	Pro00002077
Study First Received:	September 28, 2007
Results First Received:	December 12, 2012
Last Updated:	March 1, 2013
Health Authority:	United States: Food and Drug Administration

To Top