Title
Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
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.
Phase
Phase 2Lead Sponsor
Department of DefenseStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Traumatic Brain InjuryIntervention/Treatment
magnesium sulfate ...Study Participants
6The 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.
Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
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.
Subjects will have their core body temperatures lowered to 34C.
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)
| Event Type | Organ System | Event Term | Conventional Therapy | Hypothermia | Hypothermia Plus Supplemental Magnesium Sulfate Infusion |
|---|
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)
GOS score
as measured by TCD (Transcranial Doppler)
