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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
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.


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)
Primary Purpose: Other
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

Arm Intervention/treatment
Peptamen AF
over 7 days
Dietary Supplement: Peptamen AF
Each patient will receive Peptamen AF throughout the trial.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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). ]
  3. 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 ]
  4. 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 ]
  5. To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients [ Time Frame: Over 7 days ]
  6. Evaluation of the time to reach two days of stable nutrition in all patients [ Time Frame: Over 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Switzerland
Department of Intensive Care Medicine CHUV
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Nestlé
Investigators
Study Director: Bernard Cuénoud, PhD Nestec SA

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02716532     History of Changes
Other Study ID Numbers: 15.03.CLI
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Hemorrhage
Subarachnoid Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases