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Completed

NCT Number: NCT02716532

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

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Key information

Conditions

Injuries, Acute Brain Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Severe Trauma Brain Injury (sTBI) Subarachnoid Hemorrhage Subarachnoid Hemorrhage, Aneurysmal Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Intensive Care Medicine CHUV

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peptamen AF

Dietary Supplement

Each patient will receive Peptamen AF throughout the trial.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Acronym: MCTs and ABI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2016
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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