None listed
Conditions
Brief summary
This trial is a feasibility/ pilot study to establish if the administration of the treatment enteral feed (1.5 kcal/ml) increases mean daily energy delivery (kilocalorie per day) by > or equal to 20% compared to the control (1.0 kcal/ml). The study will provide baseline data to allow for the planning and funding of a larger multi centre trial to determine if delivery of additional energy to critically ill adults over the first 10 days of their ICU stay affects clinically important outcomes. Following the 10 day study treatment period, if required, patients in both groups will receive additional nutrition according to the centres standard care. The pilot study will be conducted in 6 centres in Australia with 100 patients enrolled over a six month period.
Interventions
1.5 kilocalorie per ml enteral feed formulation delivered via naso-gastric tube at a goal rate of 1ml per kilogram per hour (capped at 100ml/hr) continuously for a maximum of 10 days. Blinded enteral nutrition will cease prior to day 10 if one of the following occur: cessation of enteral nutrition by the treating clinicians, patient is discharged from the ICU, treating clinician decides that it is in the patients best interest to cease the study intervention or informed consent is withdrawn.
Sponsors
Dr Marianne Chapman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Invasive mechanically ventilated critically ill patients Expected intensive care unit stay > or = to 3 days Suitable for, or receiving (within 12 hours) enteral nutrition.
Exclusion criteria
Expected death within 24 hours Patient not for active treatment Target enteral feed volume contraindicated Requirement for specific nutritional therapy other than study enteral formulation.
Outcome results
None listed