Browsing by Author "Ospina-Tascón, Gustavo"

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    Statistical analysis plan for early goal-directed therapy using a physiological holistic view - The andromeda-shock: a randomized controlled trial
    (2018) Hernández P., Glenn; Cavalcanti, Alexandre Biasi; Ospina-Tascón, Gustavo; Dubin, Arnaldo; Hurtado, Francisco Javier; Damiani, Lucas Petri; Friedman, Gilberto; Castro López, Ricardo; Alegría, Leyla; Bakker, Jan; Cecconi, Maurizio; Teboul, Jean-Louis
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    Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial
    (Associacao de Medicina Intensiva Brasileira - AMIB, 2025) Orozco, Nicolás; Garcia-Gallardo, Gustavo; Cavalcanti, Alexandre Biasi; Dos Santos, Tiago Mendonça; Ospina-Tascón, Gustavo; Bakker, Jan; Morales Ahumada, Sebastián Alonso; Ramos, Karla; Alegría Vargas, Leyla; Teboul, Jean Louis; De Backer, Daniel; Vieillard-Baron, Antoine; Hernández, Liliana Vallecilla; de Lima, Lucas Martins; Damiani, Lucas Petri; Sady, Erica Ribeiro; Santucci, Eliana Vieira; Hernández P., Glenn; Kattan Tala, Eduardo José
    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.
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    The impact of norepinephrine dose reporting heterogeneity on mortality prediction in septic shock patients
    (2024-07-03) Morales, Sebastian; Wendel-Garcia, Pedro D.; Ibarra-Estrada, Miguel; Jung, Christian; Castro, Ricardo; Retamal, Jaime; Cortinez, Luis I.; Severino, Nicolás; Kiavialaitis, Greta E.; Ospina-Tascón, Gustavo; Bakker, Jan; Hernández, Glenn; Kattan, Eduardo
    Background: Norepinephrine (NE) is a cornerstone drug in the management of septic shock, with its dose being used clinically as a marker of disease severity and as mortality predictor. However, variations in NE dose reporting either as salt formulations or base molecule may lead to misinterpretation of mortality risks and hinder the process of care. Methods: We conducted a retrospective analysis of the MIMIC-IV database to assess the impact of NE dose reporting heterogeneity on mortality prediction in a cohort of septic shock patients. NE doses were converted from the base molecule to equivalent salt doses, and their ability to predict 28-day mortality at common severity dose cut-offs was compared. Results: 4086 eligible patients with septic shock were identified, with a median age of 68 [57–78] years, an admission SOFA score of 7 [6–10], and lactate at diagnosis of 3.2 [2.4–5.1] mmol/L. Median peak NE dose at day 1 was 0.24 [0.12–0.42] μg/kg/min, with a 28-day mortality of 39.3%. The NE dose showed significant heterogeneity in mortality prediction depending on which formulation was reported, with doses reported as bitartrate and tartrate presenting 65 (95% CI 79–43)% and 67 (95% CI 80–47)% lower ORs than base molecule, respectively. This divergence in prediction widened at increasing NE doses. When using a 1 μg/kg/min threshold, predicted mortality was 54 (95% CI 52–56)% and 83 (95% CI 80–87)% for tartrate formulation and base molecule, respectively. Conclusions: Heterogeneous reporting of NE doses significantly affects mortality prediction in septic shock. Standardizing NE dose reporting as base molecule could enhance risk stratification and improve processes of care. These findings underscore the importance of consistent NE dose reporting practices in critical care settings.