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

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dc.article.numbere20250140
dc.catalogadorgjm
dc.contributor.authorOrozco, Nicolás
dc.contributor.authorGarcia-Gallardo, Gustavo
dc.contributor.authorCavalcanti, Alexandre Biasi
dc.contributor.authorDos Santos, Tiago Mendonça
dc.contributor.authorOspina-Tascón, Gustavo
dc.contributor.authorBakker, Jan
dc.contributor.authorMorales Ahumada, Sebastián Alonso
dc.contributor.authorRamos, Karla
dc.contributor.authorAlegría Vargas, Leyla
dc.contributor.authorTeboul, Jean Louis
dc.contributor.authorDe Backer, Daniel
dc.contributor.authorVieillard-Baron, Antoine
dc.contributor.authorHernández, Liliana Vallecilla
dc.contributor.authorde Lima, Lucas Martins
dc.contributor.authorDamiani, Lucas Petri
dc.contributor.authorSady, Erica Ribeiro
dc.contributor.authorSantucci, Eliana Vieira
dc.contributor.authorHernández P., Glenn
dc.contributor.authorKattan Tala, Eduardo José
dc.date.accessioned2025-03-20T13:47:48Z
dc.date.available2025-03-20T13:47:48Z
dc.date.issued2025
dc.description.abstractBackground: ANDROMEDA-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. Objective: To report the statistical plan for the ANDROMEDA--SHOCK 2 randomized clinical trial. Methods: We 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. Conclusion: According 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.
dc.format.extent10 páginas
dc.fuente.origenSCOPUS
dc.identifier.doi10.62675/2965-2774.20250140
dc.identifier.issn2965-2774
dc.identifier.scopusidSCOPUS_ID:85216480135
dc.identifier.urihttps://doi.org/10.62675/2965-2774.20250140
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/102865
dc.information.autorucEscuela de Medicina; Morales Ahumada, Sebastián Alonso; S/I; 1067023
dc.information.autorucEscuela de Medicina; Alegría Vargas, Leyla; 0000-0002-0930-4452; 121090
dc.information.autorucEscuela de Medicina; Hernández P., Glenn; 0000-0002-3032-4087; 98874
dc.information.autorucEscuela de Medicina; Kattan Tala, Eduardo José; 0000-0002-1997-6893; 172152
dc.language.isoen
dc.nota.accesocontenido parcial
dc.publisherAssociacao de Medicina Intensiva Brasileira - AMIB
dc.revistaCritical Care Science
dc.rightsacceso restringido
dc.subjectCritical care
dc.subjectPerfusion
dc.subjectPhenotype
dc.subjectSeptic shock
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.titleStatistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial
dc.typeartículo
dc.volumen37
sipa.codpersvinculados1067023
sipa.codpersvinculados121090
sipa.codpersvinculados98874
sipa.codpersvinculados172152
sipa.trazabilidadSCOPUS;2025-02-23
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