Suspended

NUTRI_REAEfficiency and Tolerance of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula in the Critically Ill Patient : a Prospective Randomized Trial

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What is being tested

Peptamen® AF

+ Sondalis® HP

Dietary Supplement
Who is being recruted

Brain Diseases+8

+ Central Nervous System Diseases

+ Craniocerebral Trauma

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2012
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire de Besancon
Study ContactAnne-Sophie BALONMore contacts
Last updated: August 5, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01833624
Principal SponsorCentre Hospitalier Universitaire de Besancon
Study ContactAnne-Sophie BALONMore contacts
Last updated: August 5, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

206 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesTrauma, Nervous SystemDisease AttributesBrain InjuriesCritical Illness

Criteria

4 inclusion criteria required to participate
Admission in our surgical critical care unit
Expected duration of mechanical ventilation > 48 hours
Non-traumatic brain injury: stroke, intracranial and/or subarachnoid hemorrhage, subdural and/or extradural hematoma
Traumatic brain injury
4 exclusion criteria prevent from participating
Abdominal surgery in the previous 30 days
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
Pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The Control Group that will receive Sondalis ® HP (a whole-peptide formula).

Group II

Experimental
In this arm, patients have enteral nutrition with Peptamen® AF

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Surgical Critical Care Unit, CHRU Jean Minjoz

Besançon, FranceOpen Surgical Critical Care Unit, CHRU Jean Minjoz in Google Maps
SuspendedOne Study Center