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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
  Purpose

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.


Condition Intervention Phase
Brain Injury
Intracranial Pressure
 Drug: Dexmedetomidine
Drug: Propofol
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Lactate/Pyruvate (L/P)Ratio [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Precedex
Drug: Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Name: 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 Name: Precedex
Drug: Propofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Other Name: Diprivan

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538616

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Carmelo Graffagnino
Hospira, Inc.
Investigators
Principal Investigator: Carmelo Graffagnino, MD Duke University
Principal Investigator: DaiWai M Olson, PhD RN Duke University
  More Information

No publications provided

Responsible Party: Carmelo Graffagnino, Professor, 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

Keywords provided by Duke University:
Brain Injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013