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

March 1, 2013 updated by: Carmelo Graffagnino

A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Precedex-Propofol
Patients received an infusion of precedex for six hours and then a washout and then a propofol infusion for six hours.
Drug: Dexmedetomidine
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Names:
  • Precedex
Drug: Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Names:
  • Diprivan
Active Comparator: Propofol- Precedex
Patients received an infusion of propofol for six hours and then a washout and then a precedex infusion for six hours.
Drug: Dexmedetomidine
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Names:
  • Precedex
Drug: Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate/Pyruvate (L/P)Ratio
Time Frame: 1 hour
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmelo Graffagnino

Collaborators

Hospira, now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: DaiWai M Olson, PhD RN, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (Estimate)

October 2, 2007

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00002077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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