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

January 25, 2018 updated by: Nestlé

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Over 7 days
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
Time Frame: After at least 2 consecutive days of stable enteral nutrition
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).
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
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
Over 7 days
To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients
Time Frame: Over 7 days
Over 7 days
Evaluation of the time to reach two days of stable nutrition in all patients
Time Frame: Over 7 days
Over 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Study Director: Bernard Cuénoud, PhD, Nestec SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 15.03.CLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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