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

Primary Purpose

Brain Injury, Intracranial Pressure

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Sponsored by
Carmelo Graffagnino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
  • Must require (be on) mechanical ventilation
  • must require (have in place) intracranial pressure (ICP) monitoring
  • must require (be receiving) continuous IV sedation

Exclusion Criteria:

  • Bleeding diathesis
  • Glasgow Coma Scale (GCS) < 5 with fixed pupils
  • Pregnant
  • elevated ICP that requires deep sedation
  • pulmonary instability
  • Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex
  • status epilepticus
  • current neuromuscular blockade

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Precedex-Propofol

Propofol- Precedex

Arm Description

Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.

Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.

Outcomes

Primary Outcome Measures

Lactate/Pyruvate (L/P)Ratio
L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2007
Last Updated
March 1, 2013
Sponsor
Carmelo Graffagnino
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00538616
Brief Title
Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion
Acronym
PrePARE
Official Title
A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carmelo Graffagnino
Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.
Detailed Description
The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Intracranial Pressure
Keywords
Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Precedex-Propofol
Arm Type
Active Comparator
Arm Description
Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
Arm Title
Propofol- Precedex
Arm Type
Active Comparator
Arm Description
Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Primary Outcome Measure Information:
Title
Lactate/Pyruvate (L/P)Ratio
Description
L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke Must require (be on) mechanical ventilation must require (have in place) intracranial pressure (ICP) monitoring must require (be receiving) continuous IV sedation Exclusion Criteria: Bleeding diathesis Glasgow Coma Scale (GCS) < 5 with fixed pupils Pregnant elevated ICP that requires deep sedation pulmonary instability Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex status epilepticus current neuromuscular blockade
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmelo Graffagnino, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DaiWai M Olson, PhD RN
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

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