Revista Brasileira de terapia intensiva
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Rev Bras Ter Intensiva · Jul 2018
Randomized Controlled Trial Multicenter Study Comparative StudyStatistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK: a randomized controlled trial.
ANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality. ⋯ According to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.
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Rev Bras Ter Intensiva · Jul 2018
Randomized Controlled TrialExisting capacity for renal replacement therapy and site-specific practices for managing acute kidney injury at centers participating in the BaSICS trial.
To investigate the existing capacity for renal replacement therapy and site-specific practices for managing acute kidney injury at centers participating in the BaSICS trial. ⋯ There was wide variation in the availability of resources for renal replacement therapy and in the management of acute kidney injury in Brazilian intensive care units. This information should be taken into account when planning clinical trials focused on this topic in Brazil.