TY - JOUR
T1 - Plano de análise estatística para o estudo Balanced Solution versus Saline in Intensive Care Study (BaSICS)
AU - Damiani, Lucas Petri
AU - Cavalcanti, Alexandre Biasi
AU - Biondi, Rodrigo Santos
AU - Freitas, Flávio Geraldo Rezende de
AU - Figueiredo, Rodrigo Cruvinel
AU - Lovato, Wilson José
AU - Amêndola, Cristina Prata
AU - Serpa Neto, Ary
AU - Paranhos, Jorge Luiz da Rocha
AU - Veiga, Viviane Cordeiro
AU - Guedes, Marco Antonio Vieira
AU - Lúcio, Eraldo de Azevedo
AU - Oliveira Júnior, Lúcio Couto
AU - Lisboa, Thiago Costa
AU - Lacerda, Fabio Holanda
AU - Miranda, Tamiris Abait
AU - Maia, Israel Silva
AU - Grion, Cintia Magalhães Carvalho
AU - Machado, Flavia Ribeiro
AU - Zampieri, Fernando Godinho
PY - 2020/10/1
Y1 - 2020/10/1
N2 - OBJECTIVE: To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS). METHODS: BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure. RESULTS: BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days. CONCLUSION: This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.
AB - OBJECTIVE: To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS). METHODS: BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure. RESULTS: BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days. CONCLUSION: This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.
UR - https://www.scopus.com/pages/publications/85100279968
U2 - 10.5935/0103-507X.20200081
DO - 10.5935/0103-507X.20200081
M3 - Article
C2 - 33263702
AN - SCOPUS:85100279968
SN - 0103-507X
VL - 32
SP - 493
EP - 505
JO - Revista Brasileira de Terapia Intensiva
JF - Revista Brasileira de Terapia Intensiva
IS - 4
ER -