Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
Stopped early · Phase 2
Conditions studied: Traumatic Brain Injury
In brief
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.
Key facts
- Study ID
- NCT01333488
- Run by
- United States Department of Defense
- People needed
- 6
- Starts
- 2011-12-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-10-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Memorial Regional Hospital — Hollywood, Florida, United States
Full record on ClinicalTrials.gov
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