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

NCT01833624 | Unknown Phase 4 DMC

• 1 other identifier: 2012-A00078-35
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  Day 10

Study Arms (2)

Sondalis® HP

ACTIVE COMPARATOR

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

Dietary Supplement: Peptamen® AF

Peptamen® AF

EXPERIMENTAL

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

Dietary Supplement: Sondalis® HP

Interventions

Peptamen® AF DIETARY_SUPPLEMENT

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

Sondalis® HP

Sondalis® HP DIETARY_SUPPLEMENT

Peptamen® AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Nestlé Foundation: collaborator

Study Sites (1)

Surgical Critical Care Unit, CHRU Jean Minjoz

Besançon, 25030, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Critical Illness

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilles Blasco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie BALON

CONTACT

+3381668675; annesophie.balon@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2013
• First Posted: April 17, 2013
• Study Start: June 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

FR (1)