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

August 4, 2016 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • Recruiting
        • Surgical Critical Care Unit, CHRU Jean Minjoz
        • Contact:
        • Principal Investigator:
          • Gilles Blasco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day3 to Day5

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Nestlé Foundation

Investigators

  • Principal Investigator: Gilles Blasco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

February 10, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00078-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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