Evidence map›Paper›PMID 42338244›Full record

Trial reportActa anaesthesiologica Scandinavica2026

The Danish Out-of-Hospital Cardiac Arrest Trial: A Statistical Analysis Plan.

Simon Mølstrøm, Jacob E Møller, Henrik Schmidt, Anders M Grejs, Steffen Christensen, Jesper Kjærgaard, Christian Hassager, Martin A S Meyer, Lars P K Andersen, Bodil S Rasmussen and 2 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Acta anaesthesiologica Scandinavica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Simon MølstrømDepartment of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0000-0002-2778-8075
Jacob E MøllerDepartment of Clinical Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.ORCID https://orcid.org/0000-0003-2873-5845
Henrik SchmidtDepartment of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.ORCID https://orcid.org/0000-0003-1080-3344
Anders M GrejsDepartment of Intensive Care, Aarhus University Hospital, Aarhus, Denmark.ORCID https://orcid.org/0000-0002-8850-2982
Steffen ChristensenDepartment of Intensive Care, Aarhus University Hospital, Aarhus, Denmark.ORCID https://orcid.org/0000-0001-6149-7186
Jesper KjærgaardDepartment of Cardiology, the Heart Centre, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-5244-0399
Christian HassagerDepartment of Cardiology, the Heart Centre, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-1199-0981
Martin A S MeyerDepartment of Cardiology, the Heart Centre, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.ORCID https://orcid.org/0000-0002-6312-2457
Lars P K AndersenDepartment of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-0053-2560
Bodil S RasmussenDepartment of Anesthesiology and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.ORCID https://orcid.org/0000-0003-2190-145X
Jo B AndreasenDepartment of Anesthesiology and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.ORCID https://orcid.org/0000-0002-6615-4438
Sören MöllerEpidemiology, Biostatistics and Biodemography, Department of Public Health, University of Southern Denmark, Odense, Denmark.ORCID https://orcid.org/0000-0003-0858-4269

Funding

Danish Heart Foundation 2023-12401Novo Nordisk Foundation 079649
6 · The paper itself

Abstract

backgroundPost-cardiac arrest care for patients resuscitated from out-of-hospital cardiac arrest (OHCA) includes multiple pharmacological and physiological interventions, yet optimal strategies to reduce post-cardiac arrest syndrome-related morbidity and mortality remain uncertain. The DANOHCA (Danish Out-of-Hospital Cardiac Arrest) trial evaluates four such interventions-high-dose dexamethasone, prophylactic olanzapine, elevated backrest position, and early wakeup-in a factorial trial framework. This manuscript presents the complete statistical analysis plan for analyses common to all four DANOHCA interventions.

methodsDANOHCA is an investigator-initiated, multicenter, randomized, 2 × 2 × 2 × 2 factorial clinical trial enrolling comatose adult OHCA patients with a presumed cardiac etiology who achieve sustained return of spontaneous circulation, with randomization within 180 min of return of spontaneous circulation. Participants are co-randomized to Dexamethasone versus placebo, olanzapine versus placebo, backrest elevation at 35° versus 5°, and early (≤ 6 h) versus late (28-36 h) wakeup, with pharmacological interventions blinded and physiological interventions open-label. This statistical analysis plan specifies the primary and secondary outcomes, covariate adjustment, handling of missing data, assessments of interactions between interventions, and assumption checks, with all primary analyses conducted according to the intention-to-treat principle. The analysis plan is finalized prior to completion of randomization.

resultsThe primary outcomes are 90-day all-cause mortality for the dexamethasone and backrest interventions, and days alive outside hospital within 30 days for the olanzapine and early wakeup interventions, with common secondary and tertiary endpoints including mortality at later time points, neurological function, health-related quality of life, organ function, and safety outcomes. Mixed-effects regression models, Cox regression, stratified nonparametric tests, and prespecified sensitivity analyses will be applied to minimize bias and quantify intervention effects, including their associated uncertainties.

conclusionThis predefined statistical analysis plan provides a detailed, transparent framework for the primary analyses and reporting of the DANOHCA trial.

trial registrationClinical Trials Information System (CTIS): 2024-515997-28-00.

Indexed as

Out-of-Hospital Cardiac ArrestData Interpretation, StatisticalDenmarkDexamethasoneHumansOlanzapineResearch DesignDexamethasoneOlanzapinebackrest elevationDANOHCA trialdexamethasoneolanzapinepost‐cardiac arrest caresedationstatistical analysis

Identifiers

PMID42338244
PMCPMC13291755

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.