TY - JOUR
T1 - Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock
T2 - the ANDROMEDA-SHOCK-2 randomized clinical trial
AU - Orozco, Nicolas
AU - García-Gallardo, Gustavo
AU - ANDROMEDA-SHOCK-2 Investigators
AU - Cavalcanti, Alexandre Biasi
AU - Dos Santos, Tiago Mendonça
AU - Ospina-Tascón, Gustavo
AU - Bakker, Jan
AU - Morales, Sebastián
AU - Ramos, Karla
AU - Alegria, Leyla
AU - Teboul, Jean Louis
AU - De Backer, Daniel
AU - Vieillard-Baron, Antoine
AU - Fernandez, Liliana Vallecilla
AU - de Lima, Lucas Martins
AU - Damiani, Lucas Petri
AU - Sady, Erica Ribeiro
AU - Santucci, Eliana Vieira
AU - Hernandez, Glenn
AU - Kattan, Eduardo
N1 - ClinicalTrials.gov identifier: NCT05057611
EudraCT number: 2021-005358-28
Publisher Copyright:
© 2025, Associacao de Medicina Intensiva Brasileira - AMIB. All rights reserved.
PY - 2025
Y1 - 2025
N2 - Background: 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.
AB - Background: 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.
UR - http://www.scopus.com/inward/record.url?scp=85216480135&partnerID=8YFLogxK
U2 - 10.62675/2965-2774.20250140
DO - 10.62675/2965-2774.20250140
M3 - Article
AN - SCOPUS:85216480135
SN - 0103-507X
VL - 37
JO - Critical Care Science
JF - Critical Care Science
M1 - e20250140
ER -