Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
This study is currently recruiting participants.
Verified May 2013 by Department of Defense
Sponsor:
Information provided by (Responsible Party):
Greg Zorman, Department of Defense
ClinicalTrials.gov Identifier:
NCT01333488
First received: April 8, 2011
Last updated: May 17, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Traumatic Brain Injury |
Device: Arctic Sun Drug: Magnesium Sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Department of Defense:
Primary Outcome Measures:
- GOS (Glasgow Outcome Score) [ Time Frame: Discharge from Hospital - Within 2 months from Injury ] [ Designated as safety issue: No ]
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:
- GOS [ Time Frame: 3, 6 and 12 months after injury ] [ Designated as safety issue: No ]
- Vasospasm [ Time Frame: ongoing ] [ Designated as safety issue: No ]as measured by TCD (Transcranial Doppler)and transcranial arteriography
| Estimated Enrollment: | 105 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult males or females ≥ 18 years of age
- Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS) ≤ 8
- In-hospital and screened within 7 hours of injury.
- Able to obtain legally effective written consent from authorized representative
- Patients who are intubated and on mechanical ventilation
- Admitted to ICU
Exclusion Criteria:
- Bladder or rectal core temperature below 32C (89.6F) upon admission
- Clinical brain death
- Patients with open abdomens.
- Multiple orthopedic injuries (> 2 long bone fractures)
- Persistent hypotension (systolic blood pressure < 90mmHg)
- Persistent hypoxia (O2 Saturation < 94%)
- Persistent metabolic acidosis (Lactic acid > 5 mmol/L, arterial pH < 7.25)
- Positive serum pregnancy test
- Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ECG)
- History of abnormal renal function
- Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)
- Pediatric patients (< 18 years old)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333488
Contacts
| Contact: Candice Sareli, MD | 954 265 1840 | csareli@mhs.net |
Locations
| United States, Florida | |
| Memorial Regional Hospital | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Candice Sareli, MD 954-265-1840 csareli@mhs.net | |
| Principal Investigator: Greg Zorman, MD | |
| Sub-Investigator: Eddy Carrillo, MD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Greg Zorman, MD | Memorial Healthcare System |
More Information
No publications provided
| Responsible Party: | Greg Zorman, Chief of Neurosurgery, Department of Defense |
| ClinicalTrials.gov Identifier: | NCT01333488 History of Changes |
| Other Study ID Numbers: | MHS TBI Study |
| Study First Received: | April 8, 2011 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
Keywords provided by Department of Defense:
|
Traumatic Brain Injury |
Additional relevant MeSH terms:
|
Hypothermia Brain Injuries Body Temperature Changes Signs and Symptoms Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on June 18, 2013