ACTRN12618001829202CompletedPhase 2
TARGET Protein Feasibility Study: a prospective, blinded, parallel group, randomised controlled trial to assess the feasibility of conducting a phase III trial of protein targets in critically ill adults
Professor Marianne Chapman0 sites120 target enrollmentStarted: November 9, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1.Aged greater than or equal to 18 years old
- •2.Receiving invasive mechanical ventilation
- •3.About to commence EN or EN commenced within the previous 12 hours
- •4.Expected to be receiving EN in ICU beyond the calendar day following randomisation
Exclusion Criteria
- •1.Expected to be receiving any oral nutrition before the calendar day following randomisation
- •2.Any EN or PN received for >12 hours in any ICU admission in this hospital episode
- •3.Previously enrolled in this study
- •4.Treating clinician considers the EN goal rate (i.e. 1ml/kg of ideal body weight (IBW) per hour) to be clinically contraindicated e.g. requirement for fluid restriction
- •5.Treating clinician considers that either dose of protein delivered in this study is unsuitable for the patient.
- •6.Requirement for specific nutritional therapy as determined by the treating doctor or dietitian i.e. protocol EN not considered to be in the best interest of the subject
Investigators
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