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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Peptamen AF
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Injuries, Acute Brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Intensive Care Medicine CHUV

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Peptamen AF

Arm Description

over 7 days

Outcomes

Primary Outcome Measures

Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support

Secondary Outcome Measures

Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients
Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients
As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients
Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care
To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients
Evaluation of the time to reach two days of stable nutrition in all patients

Full Information

First Posted
March 17, 2016
Last Updated
January 25, 2018
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02716532
Brief Title
Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
Acronym
MCTs and ABI
Official Title
Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
May 17, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Acute Brain, Severe Trauma Brain Injury (sTBI), Subarachnoid Hemorrhage, Aneurysmal

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peptamen AF
Arm Type
Other
Arm Description
over 7 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Peptamen AF
Intervention Description
Each patient will receive Peptamen AF throughout the trial.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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).
Title
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
Title
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
Title
To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients
Time Frame
Over 7 days
Title
Evaluation of the time to reach two days of stable nutrition in all patients
Time Frame
Over 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Cuénoud, PhD
Organizational Affiliation
Nestec SA
Official's Role
Study Director
Facility Information:
Facility Name
Department of Intensive Care Medicine CHUV
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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