Study protocol for TARGET protein: The effect of augmented administration of enteral protein to critically ill adults on clinical outcomes: A cluster randomised, cross-sectional, double cross-over, clinical trial. Summers, M. J., Chapple, L. S., Bellomo, R., Chapman, M. J., Ferrie, S., Finnis, M. E., French, C., Hurford, S., Kakho, N., Karahalios, A., Maiden, M. J., O'Connor, S. N., Peake, S. L., Presneill, J. J., Ridley, E. J., Tran-Duy, A., Williams, P. J., Young, P. J., Zaloumis, S., Deane, A. M., TARGET Protein Investigators, Australian, t., & Group, N. Z. I. C. S. C. T. Critical Care and Resuscitation: Journal of the Australasian Academy of Critical Care Medicine, 25(3):147–154, September, 2023.
doi  abstract   bibtex   
BACKGROUND: It is unknown whether increasing dietary protein to 1.2-2.0 g/kg/day as recommended in international guidelines compared to current practice improves outcomes in intensive care unit (ICU) patients. The TARGET Protein trial will evaluate this. OBJECTIVE: To describe the study protocol for the TARGET Protein trial. DESIGN SETTING AND PARTICIPANTS: TARGET Protein is a cluster randomised, cross-sectional, double cross-over, pragmatic clinical trial undertaken in eight ICUs in Australia and New Zealand. Each ICU will be randomised to use one of two trial enteral formulae for three months before crossing over to the other formula, which is then repeated, with enrolment continuing at each ICU for 12 months. All patients aged ≥16 years in their index ICU admission commencing enteral nutrition will be eligible for inclusion. Eligible patients will receive the trial enteral formula to which their ICU is allocated. The two trial enteral formulae are isocaloric with a difference in protein dose: intervention 100g/1000 ml and comparator 63g/1000 ml. Staggered recruitment commenced in May 2022. MAIN OUTCOMES MEASURES: The primary outcome is days free of the index hospital and alive at day 90. Secondary outcomes include days free of the index hospital at day 90 in survivors, alive at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination. CONCLUSION: TARGET Protein aims to determine whether augmented enteral protein delivery reduces days free of the index hospital and alive at day 90. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12621001484831).
@article{summers_study_2023,
	title = {Study protocol for {TARGET} protein: {The} effect of augmented administration of enteral protein to critically ill adults on clinical outcomes: {A} cluster randomised, cross-sectional, double cross-over, clinical trial},
	volume = {25},
	issn = {1441-2772},
	shorttitle = {Study protocol for {TARGET} protein},
	doi = {10.1016/j.ccrj.2023.08.001},
	abstract = {BACKGROUND: It is unknown whether increasing dietary protein to 1.2-2.0 g/kg/day as recommended in international guidelines compared to current practice improves outcomes in intensive care unit (ICU) patients. The TARGET Protein trial will evaluate this.
OBJECTIVE: To describe the study protocol for the TARGET Protein trial.
DESIGN SETTING AND PARTICIPANTS: TARGET Protein is a cluster randomised, cross-sectional, double cross-over, pragmatic clinical trial undertaken in eight ICUs in Australia and New Zealand. Each ICU will be randomised to use one of two trial enteral formulae for three months before crossing over to the other formula, which is then repeated, with enrolment continuing at each ICU for 12 months. All patients aged ≥16 years in their index ICU admission commencing enteral nutrition will be eligible for inclusion. Eligible patients will receive the trial enteral formula to which their ICU is allocated. The two trial enteral formulae are isocaloric with a difference in protein dose: intervention 100g/1000 ml and comparator 63g/1000 ml. Staggered recruitment commenced in May 2022.
MAIN OUTCOMES MEASURES: The primary outcome is days free of the index hospital and alive at day 90. Secondary outcomes include days free of the index hospital at day 90 in survivors, alive at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination.
CONCLUSION: TARGET Protein aims to determine whether augmented enteral protein delivery reduces days free of the index hospital and alive at day 90.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12621001484831).},
	language = {eng},
	number = {3},
	journal = {Critical Care and Resuscitation: Journal of the Australasian Academy of Critical Care Medicine},
	author = {Summers, Matthew J. and Chapple, Lee-Anne S. and Bellomo, Rinaldo and Chapman, Marianne J. and Ferrie, Suzie and Finnis, Mark E. and French, Craig and Hurford, Sally and Kakho, Nima and Karahalios, Amalia and Maiden, Matthew J. and O'Connor, Stephanie N. and Peake, Sandra L. and Presneill, Jeffrey J. and Ridley, Emma J. and Tran-Duy, An and Williams, Patricia J. and Young, Paul J. and Zaloumis, Sophie and Deane, Adam M. and {TARGET Protein Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group}},
	month = sep,
	year = {2023},
	pmid = {37876373},
	pmcid = {PMC10581259},
	keywords = {Clinical Outcomes, Critical Illness, Dietary Protein, Enteral Nutrition, Nutrition Therapy},
	pages = {147--154},
}
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