Evidence map›Paper›PMID 39915843›Full record

ArticleTrials2025

TARGET Protein: the effect of augmented administration of enteral protein to critically ill adults on clinical outcomes-statistical analysis plan for a cluster randomized, cross-sectional, double cross-over, clinical trial.

Sophie Zaloumis, Matthew J Summers, Jeffrey J Presneill, Rinaldo Bellomo, Lee-Anne S Chapple, Marianne J Chapman, Adam M Deane, Suzie Ferrie, Craig French, Sally Hurford and 10 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Critical care nutrition and the legacy of Rinaldo Bellomo.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2025
    Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Sophie ZaloumisCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.
Matthew J SummersIntensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.ORCID http://orcid.org/0000-0002-6303-7148
Jeffrey J PresneillAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
Rinaldo BellomoAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
Lee-Anne S ChappleIntensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Marianne J ChapmanIntensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Adam M DeaneDiscipline of Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.
Suzie FerrieDepartment of Nutrition & Dietetics, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
Craig FrenchIntensive Care Unit, Sunshine Hospital, Melbourne, VIC, Australia.
Sally HurfordMedical Research Institute of New Zealand, Wellington, New Zealand.
Nima KakhoIntensive Care Unit, University Hospital Geelong, Geelong, VIC, Australia.
Matthew J MaidenDepartment of Critical Care, The University of Melbourne, Melbourne, Australia.
Stephanie N O'ConnorIntensive Care Unit, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Sandra L PeakeDiscipline of Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.
Emma J RidleyAustralian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
An Tran-DuyMethods and Implementation Support for Clinical and Health (MISCH) Research Hub, Faculty of Medicine, Dentistry, and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.
Patricia J WilliamsDiscipline of Acute Care Medicine, The University of Adelaide, Adelaide, South Australia, Australia.
Paul J YoungDepartment of Critical Care, The University of Melbourne, Melbourne, Australia.
Amalia KarahaliosCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia. emily.karahalios@unimelb.edu.au.
TARGET Protein Investigators, the Australian, New Zealand Intensive Care Society Clinical Trials Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe TARGET Protein trial will evaluate the effect of greater enteral protein delivery (augmented protein) on clinical outcomes of critically ill adult patients when compared to usual care.

objectiveTo describe the statistical analysis plan for the TARGET Protein trial.

methodsTARGET Protein is a cluster randomized, cross-sectional, double cross-over, open-label, registry-embedded, pragmatic clinical trial conducted across Australia and New Zealand. The trial randomized eight intensive care units (ICU) to receive enteral formula containing either higher dose enteral protein (augmented protein) or usual dose protein in a 1:1 ratio. Each ICU received one trial formula for a 3-month period and then switched to the alternate formulae. This sequence was repeated, for a total trial length of 12 months. The primary outcome is the number of days free of the index hospital and alive at day 90. Secondary outcomes include proportion of patients alive at day 90, survivor-only analysis of days free of the index hospital at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination. The statistical methods and models which will be used to estimate the effects for the primary and secondary outcomes are described. All statistical models will account for the cluster-randomized cross-over design to ensure correct estimation of the 95% confidence intervals. Trial enrolment is complete with 3412 patients enrolled. Data linkage is ongoing.

conclusionThis statistical analysis plan enables transparent reporting of the TARGET Protein trial. It will reduce the risk of potential selective reporting biases.

trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12621001484831). Registered on November 1, 2021.

Indexed as

Critical IllnessDietary ProteinsEnteral NutritionAdultAustraliaCross-Over StudiesCross-Sectional StudiesHumansIntensive Care UnitsLength of StayMulticenter Studies as TopicNew ZealandPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicRespiration, ArtificialTime FactorsDietary ProteinsCluster-randomizedCross-overDietary proteinIntensive careTrial

Identifiers

PMID39915843
PMCPMC11800547

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.