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
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
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
Start Date: June 2012
Completed Date: August 2017
Phase: Phase 4
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