Clinical trial NCT02716532: Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
Official title: Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries, Acute Brain
Severe Trauma Brain Injury (sTBI)
Subarachnoid Hemorrhage, Aneurysmal
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support
timeFrame: Over 7 days
Secondary outcomes:
measure: Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients
timeFrame: After at least 2 consecutive days of stable enteral nutrition
measure: Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients
timeFrame: Over 7 days (not necessarily at stable EN).
measure: As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients
timeFrame: Over 7 days
measure: Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care
timeFrame: Over 7 days
measure: To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients
timeFrame: Over 7 days
measure: Evaluation of the time to reach two days of stable nutrition in all patients
timeFrame: Over 7 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Intensive Care Medicine CHUV
Study officials:
affiliation: Nestec SA
name: Bernard Cuénoud, PhD
role: STUDY_DIRECTOR
References: