Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI) (MCTs and ABI)
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|ClinicalTrials.gov Identifier: NCT02716532|
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : January 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Injuries, Acute Brain Severe Trauma Brain Injury (sTBI) Subarachnoid Hemorrhage, Aneurysmal||Dietary Supplement: Peptamen AF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||May 17, 2017|
|Actual Study Completion Date :||November 15, 2017|
over 7 days
Dietary Supplement: Peptamen AF
Each patient will receive Peptamen AF throughout the trial.
- Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support [ Time Frame: Over 7 days ]
- Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Over 7 days ]
- To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients [ Time Frame: Over 7 days ]
- Evaluation of the time to reach two days of stable nutrition in all patients [ Time Frame: Over 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716532
|Department of Intensive Care Medicine CHUV|
|Lausanne, Switzerland, 1011|
|Study Director:||Bernard Cuénoud, PhD||Nestec SA|