NCT01833624

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Traumatic and/or Non-traumatic Brain Injury
• Critically Ill

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Peptamen® AF	Comparison of two types of enteral nutrition feeding: Peptamen® AF and Sondalis® HP
DIETARY_SUPPLEMENT	Sondalis® HP

Timeline

• Start date: 2012-06-01
• Primary completion: 2017-05-01
• Completion: 2017-08-01
• First posted: 2013-04-17
• Last updated: 2016-08-05

Locations

1 site across 1 country: France