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TARGET Protein Feasibility Trial

ANZICS CTG Endorsed Study

TARGET Protein Feasibility Trial

Study Description

We will administer two liquid nutrient formulae in a blinded fashion to determine whether we can deliver different amounts of protein but similar calories within a randomised clinical trial. Our trial will establish feasibility and inform a subsequent phase III randomised clinical trial to compare an intervention of augmented enteral protein delivery (i.e. as recommended by international guidelines) to standard care in mechanically ventilated critically ill adults.

Within a prospective, blinded, parallel group, randomised clinical trial we will enrol 120 patients from one of 8 ICUs. The primary outcome will be to establish treatment separation (protein delivered), with ‘augmented protein’ providing a dose of protein that is within guideline recommendations and ‘control’ representing usual standard care.

Management Committee

Adam Deane (Chair), Rinaldo Bellomo, Marianne Chapman, Lee-anne Chapple (Project Manager), Andrew Davies, Suzie Ferrie, Mark Finnis, Lorraine Little, Stephanie O’Connor, Sandra Peake, Emma Ridley, Trish Williams, and Paul Young.

Administering Institution

Royal Adelaide Hospital

Collaborators

Alfred Health, Austin Health, Frankston Hospital, Royal Adelaide Hospital, Royal Prince Alfred Hospital, Royal Melbourne Hospital, Queen Elizabeth Hospital, and Wellington Hospital.

Sample Size

120 patients

Funding

Royal Adelaide Hospital Translation Grant $250,000

Project Status as of June 2018

We have commenced preparation work with a view to commencing enrolment in March 2019.

Contact

Adam Deane (email)

Reference

CTG 1718-07