Injuries, Acute BrainMCTs and ABINCT02716532
Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
A study testing Peptamen AF in people with Injuries, Acute Brain and Severe Trauma Brain Injury (sTBI), run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injuries, Acute Brain, Severe Trauma Brain Injury (sTBI), Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Peptamen AF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to 15 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Intensive Care Medicine CHUV
Lausanne, 1011
About this study
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
- Being tested
- Peptamen AF
- Medical subject headings
- Brain Injuries, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen AFDietary supplement
Each patient will receive Peptamen AF throughout the trial.
| Study group | Role | What they receive |
|---|---|---|
| Peptamen AF | Other | over 7 days Receives: Dietary Supplement: Peptamen AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support
Measured: Over 7 days
Secondary outcomes (6)
Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients
Measured: 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
Measured: 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
Measured: 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
Measured: Over 7 days
To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients
Measured: Over 7 days
Evaluation of the time to reach two days of stable nutrition in all patients
Measured: Over 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startApr 2016
- Primary completion17 May 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries, Acute BrainStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard Cuénoud, PhD, Study director, Nestec SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716532
- Sponsor's protocol ID
- 15.03.CLI
- Acronym
- MCTs and ABI
- Status last verified
- Jan 2018
- First submitted
- 17 Mar 2016
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
- ClinicalTrials.gov ID
- NCT02716532
- Acronym / sponsor ID
- MCTs and ABI / 15.03.CLI
- Conditions
- Injuries, Acute Brain, Severe Trauma Brain Injury (sTBI), Subarachnoid Hemorrhage, Aneurysmal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peptamen AF | Other | Dietary Supplement: Peptamen AFover 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Signs of brain death or expected brain death within 48h.
- Pregnancy.
- Hemodynamic instability (circulatory shock, requiring vasopressors).
- Renal or liver insufficiency .
- Chronic intestinal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptamen AFEach patient will receive Peptamen AF throughout the trial. | Dietary supplement | Peptamen AF |
Primary outcome
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
6 secondary outcomes
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
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).
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
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
To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients
Time frame: Over 7 days
Evaluation of the time to reach two days of stable nutrition in all patients
Time frame: Over 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Cuénoud, PhD study director
Nestec SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptamen AF in people with Injuries, Acute Brain and Severe Trauma Brain Injury (sTBI), run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.