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

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage, Aneurysmal; Injuries, Acute Brain; Severe Trauma Brain Injury (sTBI)
• Intervention / Treatment: Dietary supplement: Peptamen AF

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Department of Intensive Care Medicine CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Peptamen AF; over 7 days	Dietary supplement: Peptamen AF; Each patient will receive Peptamen AF throughout the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Director: Bernard Cuénoud, PhD, Nestec SA

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): May 17, 2017
• Study Completion (ACTUAL): November 15, 2017

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (ESTIMATE): March 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Brain Injuries; Wounds and Injuries; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 15.03.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO