Traumatic and/or Non-traumatic Brain InjuryPhase 4NUTRI_REANCT01833624
Efficiency of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula
A Phase 4 study testing Peptamen® AF and Sondalis® HP in people with Traumatic and/or Non-traumatic Brain Injury and Critically Ill, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
An early and efficient enteral nutritional support could improve the clinical outcomes of brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an increased gastric residual volume frequently occurs in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic and/or Non-traumatic Brain Injury, Critically Ill
- What is being tested?
- Peptamen® AF and Sondalis® HP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Aug 2017
- Phase
- Phase 4
- 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
- Admission in our surgical critical care unit.
- Traumatic brain injury.
- Non-traumatic brain injury: stroke, intracranial and/or subarachnoid hemorrhage, subdural and/or extradural hematoma.
- Expected duration of mechanical ventilation > 48 hours.
Who cannot join
- Abdominal surgery in the previous 30 days.
- Pregnancy.
- Breast-feeding.
- Hemodynamic instability defined as infusion of norepinephrine > 3 mg/h, or epinephrine > 1 mg/h, or as increasing needs in vasopressive or inotropic drugs.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Surgical Critical Care Unit, CHRU Jean Minjoz
Besançon, 25030
Anne-Sophie BALON, +3381668675, annesophie.balon@gmail.com
Gilles Blasco
About this study
Official title: Efficiency and Tolerance of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula in the Critically Ill Patient : a Prospective Randomized Trial
An early and efficient enteral nutritional support could improve the clinical outcomes of brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an increased gastric residual volume frequently occurs in these patients.
Previous experimental studies have suggested that a small-peptide enteral feeding formula could promote the gastric emptying compared to a whole-protein formula. An improved gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily caloric intake and enhance nutritional support of brain injured critically ill patients.
Read the detailed description
This open-labelled prospective randomized trial aims to compare 2 groups of patients: the Study Group and the Control Group. The randomization process will concern the allocation of the type of enteral feeding formula administered for nutritional support: Peptamen® AF in the Study Group, and Sondalis® HP in the Control Group. 2 centers are involved in this study.
Each patient admitted in the critical care unit will be assessed for eligibility. After written informed consent is obtained from relatives, patient without any exclusion criteria will be included in the study.
The allocation of the type of enteral nutritional feeding formula will be randomized after inclusion.
Enteral nutrition according to the randomization group will start within the 48 hours of admission and up to 10 days, if requested. Beyond the 10th day, all patients will receive standard enteral nutrition formula.
After inclusion, data regarding efficacy and tolerance will be assessed daily up to day 10.
Mortality and outcome will be assessed at day 28 and at day 60.
- Being tested
- Peptamen® AF, Sondalis® HP
- Medical subject headings
- Brain Injuries, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen® AFDietary supplement
Comparison of two types of enteral nutrition feeding: Peptamen® AF and Sondalis® HP
Sondalis® HPDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Sondalis® HP | Active comparator | The Control Group that will receive Sondalis ® HP (a whole-peptide formula). Receives: Dietary Supplement: Peptamen® AF |
| Peptamen® AF | Experimental | In this arm, patients have enteral nutrition with Peptamen® AF Receives: Dietary Supplement: Sondalis® HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
the nutritional efficacy of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula in traumatic and non-traumatic brain injured critically ill patients
To compare the nutritional efficacy of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula in traumatic and non-traumatic brain injured critically ill patients.
Measured: Day3 to Day5
Secondary outcomes (1)
impact on morbidity and mortality of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic and/or Non-traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Foundation
- Responsible party
- Sponsor
- Investigators
- Gilles Blasco, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833624
- Sponsor's protocol ID
- 2012-A00078-35
- Acronym
- NUTRI_REA
- Status last verified
- Aug 2016
- First submitted
- 10 Feb 2013
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Tolerance of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula in the Critically Ill Patient : a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01833624
- Acronym / sponsor ID
- NUTRI_REA / 2012-A00078-35
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Nestlé Foundation
- Study start
- Jun 2012
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 17 Apr 2013 (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.
An early and efficient enteral nutritional support could improve the clinical outcomes of brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an increased gastric residual volume frequently occurs in these patients.
Previous experimental studies have suggested that a small-peptide enteral feeding formula could promote the gastric emptying compared to a whole-protein formula. An improved gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily caloric intake and enhance nutritional support of brain injured critically ill patients.
Detailed description
This open-labelled prospective randomized trial aims to compare 2 groups of patients: the Study Group and the Control Group. The randomization process will concern the allocation of the type of enteral feeding formula administered for nutritional support: Peptamen® AF in the Study Group, and Sondalis® HP in the Control Group. 2 centers are involved in this study.
Each patient admitted in the critical care unit will be assessed for eligibility. After written informed consent is obtained from relatives, patient without any exclusion criteria will be included in the study.
The allocation of the type of enteral nutritional feeding formula will be randomized after inclusion.
Enteral nutrition according to the randomization group will start within the 48 hours of admission and up to 10 days, if requested. Beyond the 10th day, all patients will receive standard enteral nutrition formula.
After inclusion, data regarding efficacy and tolerance will be assessed daily up to day 10.
Mortality and outcome will be assessed at day 28 and at day 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sondalis® HP | Active comparator | Dietary Supplement: Peptamen® AFThe Control Group that will receive Sondalis ® HP (a whole-peptide formula). |
| Peptamen® AF | Experimental | Dietary Supplement: Sondalis® HPIn this arm, patients have enteral nutrition with Peptamen® AF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission in our surgical critical care unit.
- Traumatic brain injury.
- Non-traumatic brain injury: stroke, intracranial and/or subarachnoid hemorrhage, subdural and/or extradural hematoma.
- Expected duration of mechanical ventilation > 48 hours.
Key exclusion criteria (4 listed)
- Abdominal surgery in the previous 30 days.
- Pregnancy.
- Breast-feeding.
- Hemodynamic instability defined as infusion of norepinephrine > 3 mg/h, or epinephrine > 1 mg/h, or as increasing needs in vasopressive or inotropic drugs.
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® AFComparison of two types of enteral nutrition feeding: Peptamen® AF and Sondalis® HP | Dietary supplement | Sondalis® HP |
| Sondalis® HP | Dietary supplement | Peptamen® AF |
Primary outcome
the nutritional efficacy of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula in traumatic and non-traumatic brain injured critically ill patients
Time frame: Day3 to Day5
To compare the nutritional efficacy of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula in traumatic and non-traumatic brain injured critically ill patients.
1 secondary outcome
impact on morbidity and mortality of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula.
Time frame: Day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
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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.
Gilles Blasco principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peptamen® AF and Sondalis® HP in people with Traumatic and/or Non-traumatic Brain Injury and Critically Ill, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Aug 2016. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie BALON (+3381668675, annesophie.balon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the nutritional efficacy of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula in traumatic and non-traumatic brain injured critically ill patients (time frame: Day3 to Day5). 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 5 Aug 2016.