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Efficiency of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula (NUTRI_REA)

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ClinicalTrials.gov Identifier: NCT01833624
Recruitment Status : Unknown
Verified August 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : April 17, 2013
Last Update Posted : August 5, 2016
Sponsor:
Collaborator:
Nestlé Foundation
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Traumatic and/or Non-traumatic Brain Injury Critically Ill Dietary Supplement: Peptamen® AF Dietary Supplement: Sondalis® HP Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2012
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : August 2017

Arm Intervention/treatment
Active Comparator: Sondalis® HP
The Control Group that will receive Sondalis ® HP (a whole-peptide formula).
Dietary Supplement: Peptamen® AF
Comparison of two types of enteral nutrition feeding: Peptamen® AF and Sondalis® HP

Experimental: Peptamen® AF
In this arm, patients have enteral nutrition with Peptamen® AF
Dietary Supplement: Sondalis® HP



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833624


Contacts
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Contact: Anne-Sophie BALON +3381668675 annesophie.balon@gmail.com

Locations
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France
Surgical Critical Care Unit, CHRU Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Anne-Sophie BALON    +3381668675    annesophie.balon@gmail.com   
Principal Investigator: Gilles Blasco         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Nestlé Foundation
Investigators
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Principal Investigator: Gilles Blasco

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01833624     History of Changes
Other Study ID Numbers: 2012-A00078-35
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Brain Injuries
Critical Illness
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Disease Attributes
Pathologic Processes