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

United States Department of Defense

Status and phase: Terminated; Phase 2

Conditions: Traumatic Brain Injury

Treatments: Drug: Magnesium Sulfate; Device: Arctic Sun

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01333488

MHS TBI Study

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Conventional Therapy

No Intervention group

Hypothermia

Experimental group

Description:

Subjects will have their core body temperatures lowered to 34C.

Treatment:

Device: Arctic Sun

Hypothermia plus supplemental magnesium sulfate infusion

Experimental group

Treatment:

Drug: Magnesium Sulfate

Device: Arctic Sun