Evidence map›Paper›PMID 41698648›Full record

ArticleActa anaesthesiologica Scandinavica2026

Albumin for Adult ICU Patients With Shock: Protocol for the INCEPT-Albumin Platform Trial Domain.

Tine Sylvest Meyhoff, Anders Perner, Praleene Sivapalan, Karen Louise Ellekjær, Aksel Karl Georg Jensen, Rikke Faebo Larsen, Maj-Brit Nørregaard Kjær, Benjamin Skov Kaas-Hansen, Theis Lange, Lasse Grønningsæter and 7 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Acta anaesthesiologica Scandinavica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

17 authors.

Tine Sylvest MeyhoffDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-1840-1596
Anders PernerDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Praleene SivapalanDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-0442-0032
Karen Louise EllekjærDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Aksel Karl Georg JensenDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Rikke Faebo LarsenDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Maj-Brit Nørregaard KjærDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Benjamin Skov Kaas-HansenDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Theis LangeCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.ORCID 0000-0001-6807-8347
Lasse GrønningsæterDepartment of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.
Maria CronhjortCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.ORCID 0000-0002-0444-8553
Carmen Andrea PfortmuellerCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Frederik KeusCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Martin Ingi SigurdssonCollaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.
Erika WilkmanPerioperative and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.ORCID 0000-0003-4250-7523
Morten Hylander MøllerDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0002-6378-9673
Anders GranholmDepartment of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-5799-7655

Funding

Dagmar Marshalls FondDanmarks Frie Forskningsfond 4308-00210BGrosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs FondNovo Nordisk Foundation NNF23OC0085106Savværksejer Jeppe Juhl og hustru Ovita Juhls MindelegatSygeforsikringen 'danmark' 2020-0320
6 · The paper itself

Abstract

backgroundIntravenous albumin is used for resuscitation of adult intensive care unit (ICU) patients with shock and substitution in those with hypoalbuminemia, which is common in critically ill patients. There is, however, substantial clinical practice variation as it is uncertain if albumin use improves patient-important outcomes.

methodsThe INCEPT-Albumin domain is an investigator-initiated, open-label domain with an integrated feasibility phase on the international, pragmatic, parallel-group, randomised, embedded, multifactorial, adaptive Intensive Care Platform Trial (INCEPT). Adult acutely admitted ICU patients with shock irrespective of its cause will be randomised to albumin versus no albumin use for resuscitation and substitution while in the ICU for a maximum of 90 days. The primary outcome is days alive without life support at 30 days. Secondary outcomes include 30-, 90-, and 180-day all-cause mortality; days alive without life support at 90 days; days alive out of hospital at 30 and 90 days; days free of delirium at 30 days; health-related quality of life and cognitive function at 180 days; and serious adverse reactions at 30 and 90 days. Analyses will primarily be conducted in the intention-to-treat population using Bayesian statistical models with neutral, weakly informative priors. We will assess feasibility after 200 participants and conduct adaptive analyses after follow-up for the primary outcome of 1000 participants and every additional 250 participants to a maximum of 10,000, with adaptive stopping for superiority/inferiority and practical equivalence (mean difference in the primary outcome < 1 day). Allocation will initially be equal, followed by response-adaptive randomisation with minimum 40% allocation to each arm. Expected sample sizes across different scenarios range from 1137 to 3547 participants, with approximately 100% probabilities of conclusiveness across scenarios.

conclusionsINCEPT-Albumin will with high probability provide conclusive results and inform clinical practice regarding albumin versus no albumin use in adult acutely admitted ICU patients with shock.

Indexed as

AlbuminsCritical CareShockAdaptive Clinical Trials as TopicAdultHumansIntensive Care UnitsMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicResearch DesignAlbuminsadaptive platform trialalbuminfluid therapyintensive carerandomised clinical trialshocktrial protocol

Identifiers

PMID41698648
PMCPMC12909088

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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.