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

Critically Ill Clinical Trial

— NUTRI_REA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01833624
• Other study ID #: 2012-A00078-35
• Status: Recruiting
• Phase: Phase 4
• First received: February 10, 2013
• Last updated: August 4, 2016
• Start date: June 2012
• Est. completion date: August 2017

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Anne-Sophie BALON
• Phone: +3381668675
• Email: annesophie.balon[@]gmail.com
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Peptamen® AF
Comparison of two types of enteral nutrition feeding: Peptamen® AF and Sondalis® HP
• Sondalis® HP

Locations

Country	Name	City	State
France	Surgical Critical Care Unit, CHRU Jean Minjoz	Besançon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Nestlé Foundation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day3 to Day5	No
Secondary	impact on morbidity and mortality of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula.		Day 10	No