Overview

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

Status:
Terminated

Trial end date:
2014-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

United States Department of Defense

Treatments:

Magnesium Sulfate

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)