LETICIA BARBOSA KAWANO DOURADO

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LIM/09 - Laboratório de Pneumologia, Hospital das Clínicas, Faculdade de Medicina

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  • article 0 Citação(ões) na Scopus
    Update in statistical analysis plan of the RENOVATE trial
    (2023) MAIA, I. S.; KAWANO-DOURADO, L.; DAMIANI, L. P.; FITZGERALD, M.; LEWIS, R. J.; CAVALCANTI, A. B.
  • article 3 Citação(ões) na Scopus
    High flow nasal catheter therapy versus non-invasive positive pressure ventilation in acute respiratory failure (RENOVATE trial): protocol and statistical analysis plan
    (2022) MAIA, Israel S.; KAWANO-DOURADO, Leticia; ZAMPIERI, Fernando G.; DAMIANI, Lucas P.; NAKAGAWA, Renato H.; GURGEL, Rodrigo M.; NEGRELLI, Karina; GOMES, Samara P. C.; PAISANI, Denise; LIMA, Lucas M.; V, Eliana Santucci; VALEIS, Nanci; LARANJEIRA, Ligia N.; LEWIS, Roger; FITZGERALD, Mark; CARVALHO, Carlos R. R.; BROCHARD, Laurent; CAVALCANTI, Alexandre B.
    Background: The best way to offer non-invasive respiratory support across several aetiologies of acute respiratory failure (ARF) is presently unclear. Both high flow nasal catheter (HFNC) therapy and non-invasive positive pressure ventilation (NIPPV) may improve outcomes in critically ill patients by avoiding the need for invasive mechanical ventilation (IMV). Objective: Describe the details of the protocol and statistical analysis plan designed to test whether HFNC therapy is non inferior or even superior to NIPPV in patients with ARF due to different aetiologies. Methods: RENOVATE is a multicentre adaptive randomised controlled trial that is recruiting patients from adult emergency departments, wards and intensive care units (ICUs). It takes advantage of an adaptive Bayesian framework to assess the effectiveness of HFNC therapy versus NIPPV in four subgroups of ARF (hypoxaemic non-immunocompromised, hypoxaemic immunocompromised, chronic obstructive pulmonary disease exacerbations, and acute cardiogenic pulmonary oedema). The study will report the posterior probabilities of non-inferiority, superiority or futility for the comparison between HFNC therapy and NIPPV. The study assumes neutral priors and the final sample size is not fixed. The final sample size will be determined by a priori determined stopping rules for non-inferiority, superiority and futility for each subgroup or by reaching the maximum of 2000 patients. Outcomes: The primary endpoint is endotracheal intubation or death within 7 days. Secondary outcomes are 28-day and 90-day mortality, and ICU-free and IMV-free days in the first 28 days. Results and conclusions: RENOVATE is designed to provide evidence on whether HFNC therapy improves, compared with NIPPV, important patient-centred outcomes in different aetiologies of ARF. Here, we describe the rationale, design and status of the trial. Trial registration: ClinicalTrials.gov NCT03643939.
  • article 44 Citação(ões) na Scopus
    Study protocol for the Balanced Solution versus Saline in Intensive Care Study (BaSICS): a factorial randomised trial
    (2017) ZAMPIERI, Fernando G.; AZEVEDO, Luciano C. P.; CORREA, Thiago D.; FALAVIGNA, Maicon; MACHADO, Flavia R.; ASSUNCAO, Murillo S. C. de; LOBO, Suzana M. A.; DOURADO, Leticia K.; BERWANGER, Otavio; KELLUM, John A.; BRANDAO, Nilton; CAVALCANTI, Alexandre B.
    Background: The effectiveness and safety of balanced crystalloid fluids compared with saline (0.9% sodium chloride) as a fluid of choice in critically ill patients remain unclear. The effects of different fluid infusion rates on outcomes are also unknown. Objectives: To test the hypothesis that a balanced crystalloid solution, compared with saline, decreases 90-day all-cause mortality among critically ill patients; and to test the hypothesis that slow, compared with rapid, infusion rate decreases 90-day mortality in this population of patients. Methods: The Balanced Solution versus Saline in Intensive Care Study (BaSICS) is a pragmatic, 2 x 2 factorial, randomised controlled trial. A total of 11 000 patients will be recruited from at least 100 Brazilian intensive care units. Patients will be randomised to receive Plasma-Lyte 148 or saline, and to rapid infusion (999 mL/h) or slow infusion (333 mL/h). Study fluids will be used for resuscitation episodes (at rapid or slow infusion rates), dilution of compatible medications and maintenance solutions. Patients, health care providers and investigators will be blinded to the solutions being tested. The rate of bolus infusion will not be blinded. Outcomes: The primary outcome is 90-day all-cause mortality. Secondary outcomes are: incidence of renal failure requiring renal replacement therapy within 90 days, incidence of acute kidney injury (Kidney Disease: Improving Global Outcomes stages 2 and 3), incidence of non-renal organ dysfunction assessed by Sepsis-related Organ Failure Assessment score at Days 3 and 7, and number of mechanical ventilation free days within the first 28 days after randomisation. Results and conclusions: The BaSICS trial will provide robust evidence on whether a balanced crystalloid, compared with saline, improves important patient outcomes in critically ill patients. BaSICS will also provide relevant information on whether bolus infusion rate affects outcomes in this population.