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

Traumatic Brain Injury Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01333488
• Other study ID #: MHS TBI Study
• Status: Terminated
• Phase: Phase 2
• First received: April 8, 2011
• Last updated: October 27, 2015
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: United States Department of Defense
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Hypothermia
• Traumatic Brain Injury

Intervention

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

Drug:
• 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.

Locations

Country	Name	City	State
United States	Memorial Regional Hospital	Hollywood	Florida

Sponsors (1)

Lead Sponsor	Collaborator
United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GOS (Glasgow Outcome Score)	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)	Discharge from Hospital - Within 2 months from Injury	No
Secondary	GOS	GOS score	12 months after injury	No
Secondary	Vasospasm	as measured by TCD (Transcranial Doppler)	up to 3 months	No