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

NCT ID: NCT01333488

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-06-30

Brief 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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hypothermia

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

Group Type: EXPERIMENTAL

Arctic Sun

Intervention Type: DEVICE

Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.

Hypothermia plus supplemental magnesium sulfate infusion

Group Type: EXPERIMENTAL

Arctic Sun

Intervention Type: DEVICE

Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.

Magnesium Sulfate

Intervention Type: DRUG

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.

Interventions

Arctic Sun

Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: lead

Responsible Party

Greg Zorman

Chief of Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Greg Zorman, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Healthcare System

Locations

Memorial Regional Hospital

Hollywood, Florida, United States

Countries

United States

Other Identifiers

MHS TBI Study

Identifier Type: -

Identifier Source: org_study_id