NCT02716532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

March 17, 2016

Last Update Submit

January 25, 2018

Conditions

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

Outcome Measures

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

    Over 7 days

Secondary Outcomes (6)

  • 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

  • Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients

    Over 7 days (not necessarily at stable EN).

  • 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

  • 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

  • To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients

    Over 7 days

  • +1 more secondary outcomes

Study Arms (1)

Peptamen AF

OTHER

over 7 days

Dietary Supplement: Peptamen AF

Interventions

Peptamen AFDIETARY_SUPPLEMENT

Each patient will receive Peptamen AF throughout the trial.

Peptamen AF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Care Medicine CHUV

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Brain InjuriesSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bernard Cuénoud, PhD

    Nestec SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 23, 2016

Study Start

April 1, 2016

Primary Completion

May 17, 2017

Study Completion

November 15, 2017

Last Updated

January 29, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)