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Traumatic and/or Non-traumatic Brain Injury | Efficiency of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula

Traumatic and/or Non-traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic and/or Non-traumatic Brain Injury

Critically Ill

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Dietary Supplement:Sondalis® HP

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Unknown status

Start Date: June 2012

Completed Date: August 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: 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

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

Study sponsors, principal investigator, and references

Principal Investigator: Gilles Blasco

Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Collaborator: Nestlé Foundation

More information:https://clinicaltrials.gov/show/NCT01833624

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