Status:
UNKNOWN
Efficiency of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Collaborating Sponsors:
Nestlé Foundation
Conditions:
Traumatic and/or Non-traumatic Brain Injury
Critically Ill
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 re...
Detailed 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 entera...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2017
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT01833624
Start Date
June 1 2012
End Date
August 1 2017
Last Update
August 5 2016
Active Locations (1)
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1
Surgical Critical Care Unit, CHRU Jean Minjoz
Besançon, France, 25030