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

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

— MCTs and ABI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716532
• Other study ID #: 15.03.CLI
• Status: Completed
• Phase: N/A
• First received: March 17, 2016
• Last updated: January 25, 2018
• Start date: April 2016
• Est. completion date: November 15, 2017

Study information

• Verified date: January 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 15, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Peptamen AF
Each patient will receive Peptamen AF throughout the trial.

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care Medicine CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support		Over 7 days
Secondary	Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients		After at least 2 consecutive days of stable enteral nutrition
Secondary	Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients		Over 7 days (not necessarily at stable EN).
Secondary	As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients		Over 7 days
Secondary	Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care		Over 7 days
Secondary	To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients		Over 7 days
Secondary	Evaluation of the time to reach two days of stable nutrition in all patients		Over 7 days