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

NCT ID: NCT02716532

Last Updated: 2018-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-11-15

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Peptamen AF

over 7 days

Group Type: OTHER

Peptamen AF

Intervention Type: DIETARY_SUPPLEMENT

Each patient will receive Peptamen AF throughout the trial.

Interventions

Peptamen AF

Each patient will receive Peptamen AF throughout the trial.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Cuénoud, PhD

Role: STUDY_DIRECTOR

Nestec SA

Locations

Department of Intensive Care Medicine CHUV

Lausanne, , Switzerland

Countries

Switzerland

Other Identifiers

15.03.CLI

Identifier Type: -

Identifier Source: org_study_id