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TARGET Protein Feasibility Trial

ANZICS CTG Endorsed Study

TARGET Protein Feasibility Trial

Study Description

TARGET Protein Feasibility Trial will compare the administration of two liquid nutrient formulae in a blinded fashion to determine whether two different amounts of protein but similar calories can be delivered enterally 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 6 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, Sally Hurford, Lorraine Little, Stephanie O’Connor, Sandra Peake, Emma Ridley, Matthew Summers (Project Manager), Trish Williams and Paul Young

Administering Institution

Royal Adelaide Hospital

Collaborators

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

Sample Size

120 patients

Funding

Royal Adelaide Hospital Translation Grant $250,000

Project Status as of June 2019

Randomisation of 120 patients at 6 participating sites occurred between 14 April and 2 July 2019 (84 days of recruitment). The final data point (day 90 mortality) will be due on 2 October 2019. Provisional plan to present results to ANZICS CTG community in Noosa (March 2020)

Reference

CTG 1718-07

Contact

Adam Deane (email)