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Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01333488
Recruitment Status : Terminated (Low accrual)
First Posted : April 12, 2011
Results First Posted : September 30, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Greg Zorman, United States Department of Defense

Study Description
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Brief Summary:

The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.

This is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the following three groups:

Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have their core body temperature lowered to 34C Group 3 - Subjects will have their core body temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium sulfate.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Arctic Sun Drug: Magnesium Sulfate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Controlled 2x3 Trial Comparing Clinical Outcomes in Patients With Severe Traumatic Brain Injury Using Mild Hypothermia and Concurrent and Supplemental Infusion of Magnesium Sulfate.
Study Start Date : December 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Conventional Therapy
Experimental: Hypothermia
Subjects will have their core body temperatures lowered to 34C.
 Device: Arctic Sun
Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
Experimental: Hypothermia plus supplemental magnesium sulfate infusion Device: Arctic Sun
Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.

Drug: Magnesium Sulfate
IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours.


Outcome Measures
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Primary Outcome Measures :
  1. GOS (Glasgow Outcome Score) [ Time Frame: Discharge from Hospital - Within 2 months from Injury ]

    GOS=5 (Good Recovery) - Capacity to resume normal occupational and social activities, although some there may be some minor physical or mental deficits or symptoms.

    GOS=4 (Moderate Disability) - Independent and can resume almost all activities of daily living.

    GOS=3 (Severe Disability) - No longer capable of engaging in most previous personal, social or work activities. Typically are partially or totally dependent on assistance from others in daily living.

    GOS=2 ( Persistent Vegetative State ) GOS=1 (Dead)



Secondary Outcome Measures :
  1. GOS [ Time Frame: 12 months after injury ]
    GOS score

  2. Vasospasm [ Time Frame: up to 3 months ]
    as measured by TCD (Transcranial Doppler)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult males or females ≥ 18 years of age
  2. Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS) ≤ 8
  3. In-hospital and screened within 7 hours of injury.
  4. Able to obtain legally effective written consent from authorized representative
  5. Patients who are intubated and on mechanical ventilation
  6. Admitted to ICU

Exclusion Criteria:

  1. Bladder or rectal core temperature below 32C (89.6F) upon admission
  2. Clinical brain death
  3. Patients with open abdomens.
  4. Multiple orthopedic injuries (> 2 long bone fractures)
  5. Persistent hypotension (systolic blood pressure < 90mmHg)
  6. Persistent hypoxia (O2 Saturation < 94%)
  7. Persistent metabolic acidosis (Lactic acid > 5 mmol/L, arterial pH < 7.25)
  8. Positive serum pregnancy test
  9. Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ECG)
  10. History of abnormal renal function
  11. Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)
  12. Pediatric patients (< 18 years old)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333488


Locations
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United States, Florida
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Sponsors and Collaborators
United States Department of Defense
Investigators
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Principal Investigator: Greg Zorman, MD Memorial Healthcare System
More Information
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Responsible Party: Greg Zorman, Chief of Neurosurgery, United States Department of Defense
ClinicalTrials.gov Identifier: NCT01333488    
Other Study ID Numbers: MHS TBI Study
First Posted: April 12, 2011    Key Record Dates
Results First Posted: September 30, 2015
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Greg Zorman, United States Department of Defense:
Traumatic
Brain
Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Hypothermia
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Body Temperature Changes
Magnesium Sulfate
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents