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

Phase 4

• Conditions: Critically Ill; Traumatic and/or Non-traumatic Brain Injury
• Interventions: Dietary Supplement: Peptamen® AF; Dietary Supplement: Sondalis® HP

• Registration Number: NCT01833624
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-02-10
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-17
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-05
• Primary Completion: 2017-05
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sondalis® HP	Peptamen® AF	The Control Group that will receive Sondalis ® HP (a whole-peptide formula).
Peptamen® AF	Sondalis® HP	In this arm, patients have enteral nutrition with Peptamen® AF

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
impact on morbidity and mortality of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula.	Day 10

Trial Locations

Locations (1)

Surgical Critical Care Unit, CHRU Jean Minjoz; 🇫🇷 Besançon, France