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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02716532
Other study ID # 15.03.CLI
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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