Status:
ENROLLING_BY_INVITATION
Ketogenic Diet & Functional Recovery in Moderate to Severe Traumatic Brain Injury
Lead Sponsor:
Loma Linda University
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
16-90 years
Phase:
NA
Brief Summary
Traumatic Brain Injury (TBI) represents a significant public health risk in the United States leaving many survivors with significant long term cognitive deficits and at risk for neurodegenerative dis...
Detailed Description
Traumatic Brain Injury (TBI) represents a significant public health risk in the United States leaving many survivors with significant long term cognitive deficits and at risk for neurodegenerative dis...
Eligibility Criteria
Inclusion
- complicated mild (GCS 13-15), moderate (GCS 9 - 12) to severe (GCS ≤ 8) traumatic brain injury (TBI) between 2-30 days post injury
- Admitted to Loma Linda University surgical intensive care unit (SICU)
Exclusion
- history of comorbid ischemic stroke following qualifying TBI
- history of premorbid brain injury with associated loss of consciousness
- history of psychiatric disorder
- history of premorbid neurological disorder or neurosurgical intervention
- pregnancy
- depressed GCS score due to acute intoxication
- liver dysfunction as defined by liver enzymes 5 times the upper limit of normal or chronic cirrhosis
- acute renal failure according to the Risk, Injury, Failure, Loss of kidney function, and End-stage kidenty disease (RIFLE) classification
- abdominal surgery during the same admission
- type 1 diabetes
- gastroparesis
- dyslipidemia
- severe asphasia
- known history of metabolic disorders that are a contradiction for ketogenic diet (KD) such as primary carnitine deficient, carnitine palmitoyltransferase (CPT) I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, pyruvate carboxylase deficiency, or porphyria
- prealbumin (transthyretin) levels of \<10 mg/dL within 3 days of admission
- Metal, implanted device (ICP monitor), pregnancy, claustrophobia, or other contraindication to MRI
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04530032
Start Date
December 7 2020
End Date
December 1 2025
Last Update
January 15 2025
Active Locations (1)
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1
Loma Linda University Health
Loma Linda, California, United States, 92354