Overview

Ketogenic Diet for Traumatic Brain Injury

Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
All
Summary
Traumatic Brain Injury is a major health concern in United States. There is a un-met need to develop new therapeutic options for faster neuron recovery without causing significant side effects. The role of ketones in neuronal recovery has been studied and has been found to be useful in decreasing size of contusion. The present study aims to study the safety and feasibility profile of ketogenic diet.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Missouri-Columbia
Criteria
Inclusion Criteria:

1. Severe Traumatic Brain Injury

2. GCS<= 8 with severe head injury

3. Age more than 18years

Exclusion Criteria:

1. Diabetic Ketoacidosis

2. Unstable metabolic condition (persistent hyponatremia, hypernatremia, hypoglycemia,
hypocalcemia, acidosis)

3. Cardiorespiratory or hemodynamic instability

4. Coagulopathy

5. Pancreatitis

6. Liver Failure

7. Severe hyperlipidemia

8. Inability to tolerate enteral feeds including ileus

9. Known Fatty acid oxidation disorder or pyruvate carboxylase deficiency

10. Any terminally ill patient with poor brain stem reflexes and mortality within 24h of
admission.

11. Pregnant Females