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

Centre Hospitalier Universitaire de Besancon

Status and phase: Unknown; Phase 4

Conditions: Critically Ill; Traumatic and/or Non-traumatic Brain Injury

Treatments: Dietary Supplement: Peptamen® AF; Dietary Supplement: Sondalis® HP

Study type: Interventional

Funder types: Other

Identifiers

NCT01833624

2012-A00078-35

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Sondalis® HP

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Peptamen® AF

Peptamen® AF

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sondalis® HP