Evidence map›Paper›PMID 39879432›Full record

ArticleCritical care science2025

Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial.

Nicolas Orozco, Gustavo García-Gallardo, Alexandre Biasi Cavalcanti, Tiago Mendonça Dos Santos, Gustavo Ospina-Tascón, Jan Bakker, Sebastián Morales, Karla Ramos, Leyla Alegria, Jean Louis Teboul and 9 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Critical care science, 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. Trial
  2. 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

19 authors.

Nicolas OrozcoDepartment of Intensive Care Medicine, Fundación Valle del Lili - Cali, Colombia.ORCID http://orcid.org/0000-0003-1054-3749
Gustavo García-GallardoDepartment of Intensive Care Medicine, Fundación Valle del Lili - Cali, Colombia.ORCID http://orcid.org/0000-0001-6224-7496
Alexandre Biasi CavalcantiHCor Research Institute, HCor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-2798-6263
Tiago Mendonça Dos SantosHCor Research Institute, HCor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-4223-9162
Gustavo Ospina-TascónDepartment of Intensive Care Medicine, Fundación Valle del Lili - Cali, Colombia.ORCID http://orcid.org/0000-0001-9370-3298
Jan BakkerDepartment of Intensive Care Adults, Erasmus MC University Medical Center - Rotterdam, Netherlands.ORCID http://orcid.org/0000-0003-2236-7391
Sebastián MoralesDepartamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile - Santiago, Chile.ORCID http://orcid.org/0009-0001-4474-615X
Karla RamosDepartamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile - Santiago, Chile.ORCID http://orcid.org/0009-0008-4831-7089
Leyla AlegriaDepartamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile - Santiago, Chile.ORCID http://orcid.org/0000-0002-0930-4452
Jean Louis TeboulFaculté de Médecine, Paris-Saclay University - Le Kremlin-Bicêtre, France.ORCID http://orcid.org/0000-0002-5748-7820
Daniel De BackerDepartment of Intensive Care, CHIREC Hospitals, Université Libre de Bruxelles - Brussels, Belgium.ORCID http://orcid.org/0000-0001-9841-5762
Antoine Vieillard-BaronMedical and Surgical ICU, University Hospital Ambroise-Paré - Boulogne-Billancourt, France.ORCID http://orcid.org/0000-0002-4179-3583
Liliana Vallecilla FernandezCentro de Investigaciones Clínicas, Fundación Valle del Lili -Cali, Colombia.ORCID http://orcid.org/0000-0002-5946-2408
Lucas Martins de LimaHCor Research Institute, HCor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0009-0004-2282-8850
Lucas Petri DamianiHCor Research Institute, HCor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-5836-3379
Erica Ribeiro SadyHCor Research Institute, HCor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-2390-1605
Eliana Vieira SantucciHCor Research Institute, HCor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0009-0000-0880-2479
Glenn HernandezDepartamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile - Santiago, Chile.ORCID http://orcid.org/0000-0002-3032-4087
Eduardo KattanDepartamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile - Santiago, Chile.ORCID http://orcid.org/0000-0002-1997-6893

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundANDROMEDA-SHOCK 2 is an international, multicenter, randomized controlled trial comparing hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock to standard care resuscitation to test the hypothesis that the former is associated with lower morbidity and mortality in terms of hierarchal analysis of outcomes.

objectiveTo report the statistical plan for the ANDROMEDA--SHOCK 2 randomized clinical trial.

methodsWe briefly describe the trial design, patients, methods of randomization, interventions, outcomes, and sample size. We portray our planned statistical analysis for the hierarchical primary outcome using the stratified win ratio method, as well as the planned analysis for the secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables, baseline characteristics, and the effects of treatments on outcomes.

conclusionAccording to best trial practices, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this practice will prevent analysis bias and improve the utility of the study's reported results.

Indexed as

HemodynamicsResuscitationShock, SepticCapillariesHumansMulticenter Studies as TopicPhenotypeRandomized Controlled Trials as Topic

Identifiers

PMID39879432
PMCPMC11805453

What OpenQuestion holds

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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.