Remote monitoring of automated peritoneal dialysis reduces mortality, adverse events and hospitalizations: a cluster-randomized controlled trial
Ramón Paniagua, Alfonso Ramos, Marcela Ávila, María-de-Jesús Ventura, Armando Nevárez-Sida, Abdul Rashid Qureshi, Bengt Lindholm, Mexican Nephrology Collaborative Study Group, Diana Pérez-Morán, Miguel Ángel Trejo Villeda, María D Zavaleta-Diaz, Beatriz Hernández-Franco, Alejandro B Hinojosa-Rojas, Leysy Rosales-Chavarría, María R Romano-Bárcenas, Juana Morales-Monterrosas, Jovita Hijui-Xopa, María-Guadalupe Suárez-López, Belisario Domínguez-Mancera, Mario Rojas-Díaz, Nancy Ávila-Ortega, C. C. McGregor, Angelica Cruz-Baltazar, Rubén Acosta-Jurado, María Begonia-Ilabaca, Patricia Gómez-Torres, Emilia Cantoral-Farfán, Norberto Ávila-Osorio, Cristina Rodríguez-Esquivel, Lucina Hernández-Cervantes, Fabiola Reyes, Clara V Ramírez-Loera, M C Ortega Camarillo, Alejandro Sánchez-Mendoza, Israel Chávez-Palacios, Adrián Ramírez-Cárdenas, Ofelia Galván-Vela, Diana P García-Velásquez, Edith M De-León-Lagunas, Ofelia Sáenz-Flores, David Utrera-Ruiz, María I Rivera-Juárez, María A Soto-Gómez, Margarita Jiménez-Garzón, Marco A Nepomuceno De Florencio, José F Álvarez-Reséndiz, Sandra Rodríguez-Badillo, María E Solís-Gómez, María E Reyes-López-León, María L Romo-Flores, Víctor I Tejeda-González, Laura Elizabeth Aguilar-Fletes, Samara A Plascencia-Coutiño, Ámbar P Uriarte-Loaiza, Alvarado Ibarra Martha, Padilla-Mercado, Karina Arroyo-Cuevas, Laura M Díaz-Canchola, Laura Quezada-Jauregui, Daniel Gil-Romero, Alma D Cansino-Villagómez, Silverio Lara-Robles, María T Muñoz-Rivera, Rosenda A Zurita-Rodríguez, Teresita J Rodríguez-Vega
Abstract
BACKGROUND: Remote monitoring (RM) of patients on automated peritoneal dialysis (APD) prevents complications and improves treatment quality. We analyzed the effect of RM-APD on mortality and complications related to cardiovascular disease, fluid overload and insufficient dialysis efficiency. METHODS: In a cluster-randomized, open-label, controlled trial, 21 hospitals with APD programs were assigned to use either RM-APD (10 hospitals; 403 patients) or conventional APD (11 hospitals; 398 patients) for the treatment of adult patients starting PD. Primary outcomes were time to first event of: (i) Composite Index 1 comprising all-cause mortality, first adverse events and hospitalizations of any cause, and (ii) Composite Index 2 comprising cardiovascular mortality, first adverse event and hospitalizations related to cardiovascular disease, fluid overload and insufficient dialysis efficiency. Secondary outcomes were time to first event of individual components of the two composite indices, and rates of adverse events, hospitalizations, unplanned visits and transfer to hemodialysis. Patients were followed for a median of 9.5 months. Primary outcomes were evaluated by competing risk analysis and restricted mean survival time (RMST) analysis. RESULTS: While time to reach Composite Index 1 did not differ between the groups, Composite Index 2 was reached earlier (ΔRMST: -0.86 months; P = .02), and all-cause mortality [55 vs 33 deaths, P = .01; sub-hazard ratio (sHR) 1.69 (95% confidence interval 1.39-2.05), P < .001] and hospitalizations of any cause were higher in APD group than in RM-APD as were cardiovascular deaths [24 vs 13 deaths, P = .05; sHR 2.44 (95% confidence interval 1.72-3.45), P < .001] and rates of adverse events and hospitalizations related to cardiovascular disease, fluid overload or insufficient dialysis efficiency. Dropouts were more common in the APD group (131 vs 110, P = .048). CONCLUSIONS: This randomized controlled trial shows that RM may add significant advantages to APD, including improved survival and reduced rate of adverse events and hospitalizations, which can favorably impact the acceptance and adoption of the therapy.