Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)

Study Overview
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Brief Summary
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This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH). This clinical study is an open-label, non-randomized, single-center, exploratory metabolic study. The primary objective is to determine changes from baseline (before enteral administration of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI patients upon Peptamen AF nutritional support.

Official Title
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Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)

Conditions
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Injuries, Acute Brain, Severe Trauma Brain Injury (sTBI), Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
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* Dietary Supplement: Peptamen AF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Comatose patients (defined by an initial Glasgow Coma Scale (GCS) < 9) following sTBI or aSAH. Female or male, aged >18. Abnormal head CT-Scan (contusions, hematoma). Intracranial monitoring with CMD, [PbtO2] and [ICP] probes as part of standard of care. Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests. Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study Exclusion Criteria: Signs of brain death or expected brain death within 48h. Pregnancy. Hemodynamic instability (circulatory shock, requiring vasopressors). Renal or liver insufficiency . Chronic intestinal disease. Patients requiring parenteral nutrition . Currently participating or having participated in another clinical trial during the month preceding the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peptamen AF<br>over 7 days | Dietary Supplement: Peptamen AF<br>* Each patient will receive Peptamen AF throughout the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support |  | Over 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients |  | After at least 2 consecutive days of stable enteral nutrition | 
| Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients |  | Over 7 days (not necessarily at stable EN). | 
| As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients |  | Over 7 days | 
| Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care |  | Over 7 days | 
| To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients |  | Over 7 days | 
| Evaluation of the time to reach two days of stable nutrition in all patients |  | Over 7 days |