Efficiency of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula
NCT ID: NCT01833624
Last Updated: 2016-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
206 participants
INTERVENTIONAL
2012-06-30
2017-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sondalis® HP
The Control Group that will receive Sondalis ® HP (a whole-peptide formula).
Peptamen® AF
Comparison of two types of enteral nutrition feeding: Peptamen® AF and Sondalis® HP
Peptamen® AF
In this arm, patients have enteral nutrition with Peptamen® AF
Sondalis® HP
Interventions
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Peptamen® AF
Comparison of two types of enteral nutrition feeding: Peptamen® AF and Sondalis® HP
Sondalis® HP
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Nestlé Foundation
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Gilles Blasco
Role: PRINCIPAL_INVESTIGATOR
Locations
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Surgical Critical Care Unit, CHRU Jean Minjoz
Besançon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2012-A00078-35
Identifier Type: -
Identifier Source: org_study_id
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