Evidence map›Paper›PMID 39977382›Full record

ArticlePloS one2025

Muscle growth and anabolism in intensive care survivors (GAINS 2.0): Protocol for a multi-centre randomised; placebo controlled clinical trial of nandrolone in deconditioned adults recovering from critical illness.

Matthew Anstey, Ed Litton, Maryam Habibi, Lisa Van der Lee, Robert Palmer, Natalie Tran, Bianca Mammana, Stacey Scheepers, Annamaria Palermo, Xavier Fiorilla and 4 more

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

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

14 authors.

Matthew AnsteyIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.ORCID https://orcid.org/0000-0001-7927-524X
Ed LittonSchool of Medicine, University of Western Australia, Perth, Western Australia, Australia.
Maryam HabibiSchool of Medicine, University of Western Australia, Perth, Western Australia, Australia.ORCID https://orcid.org/0009-0006-3251-9669
Lisa Van der LeeIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Robert PalmerIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Natalie TranIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.ORCID https://orcid.org/0000-0003-4879-5132
Bianca MammanaIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Stacey ScheepersIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Annamaria PalermoIntensive Care Department, Fiona Stanley Hospital, Perth, Western Australia, Australia.
Xavier FiorillaIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Bhaumik MevavalaIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.ORCID https://orcid.org/0000-0003-4398-3177
Adrian RegliIntensive Care Department, St John of God Hospital Murdoch, Perth, Western Australia, Australia.ORCID https://orcid.org/0000-0002-3960-6013
Angela JacquesInstitute for Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.
Bradley WibrowIntensive Care Department, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntensive care patients can experience significant long-term impairment in mobility and function caused by their critical illness. A potential contributory factor apart from critical illness polymyoneuropathy is the low levels of anabolic hormones in these patients. Testosterone levels in critically ill patients are extremely low, even in the latter recovery phase. A potential solution to critical illness myopathy may be to provide anabolic support in addition to standard care (early physiotherapy) to further improve gains in strength. RESEARCH QUESTION: This project aims to test whether a synthetic testosterone (nandrolone) improves muscle strength in ICU survivors compared to placebo.

methodsGAINS 2.0 is a multicentre, randomised, double blinded placebo-controlled trial which will allocate ICU patients in a 1:1 ratio to nandrolone compared to placebo which commenced recruitment in July 2023. Adult patients admitted to the ICU, receiving nutrition for a minimum of 24 hours with an ICU stay of at least 5 days, or patients with significant weakness as result of their ICU stay (such that they are unable to mobilise independently) will be eligible to participate. Sample size will be 54 patients. Patients will be randomised to receive nandrolone 100mg (males) / 50mg(females) weekly for 3 weeks in addition to standard care. The co-primary outcomes are the time to walking with one person assisting (Intensive Care Mobility scale = 8 or more, in days from randomisation), change in muscle strength measured by the Medical Research Council (MRC) muscle strength sum score from enrolment to hospital discharge and number of days out of hospital up to day 90 post-discharge. Secondary outcomes are grip strength measured by hand-held dynamometry. SF-36 scores (quality of life and functional domains), and days to return to work, for those working pre-ICU, will be collected via a 3-month phone follow-up.

conclusionsA previous pilot feasibility trial showed that nandrolone is safe and feasible. We hypothesize nandrolone will improve muscle strength and physical functioning at hospital discharge and at follow-up. The results of this trial may have significant interest to clinicians and patients considering the large and increasing number of patients surviving intensive care but with physical impairment. This trial may have significant implications on lowering hospital costs and daily adjusted life years. TRIAL REGISTRY: anzctr.org.au; No.: ACTRN12623000729628 URL: anzctr.org.au.

Indexed as

Anabolic AgentsCritical IllnessMuscle DevelopmentNandroloneAdultCritical CareDouble-Blind MethodFemaleHumansIntensive Care UnitsMaleMiddle AgedMulticenter Studies as TopicMuscle StrengthRandomized Controlled Trials as TopicSurvivorsAnabolic AgentsNandrolone

Identifiers

PMID39977382
PMCPMC11841879

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.