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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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 ]
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
|Contact: Anne-Sophie BALONemail@example.com|
|Surgical Critical Care Unit, CHRU Jean Minjoz||Recruiting|
|Besançon, France, 25030|
|Contact: Anne-Sophie BALON +3381668675 firstname.lastname@example.org|
|Principal Investigator: Gilles Blasco|
|Principal Investigator:||Gilles Blasco|