RT Journal Article
T1 Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial
A1 Suárez Carantoña, Cecilia
A1 Escobar Cervantes, Carlos
A1 Fabregate Fuente, Martín
A1 López Rodríguez, Mónica
A1 Bara Ledesma, Nuria
A1 Soto Pérez-Olivares, Javier
A1 Ruiz Ortega, Raúl Antonio
A1 López Castellanos, Genoveva
A1 Olavarría Delgado, Andreina
A1 Blázquez Sánchez, Javier
A1 Gómez del Olmo, Vicente
A1 Moralejo Martín, Myriam
A1 Pumares Álvarez, María Belén
A1 Sánchez Gallego, María De La Concepción
A1 Llàcer Iborra, Pau
A1 Liaño García, Fernando
A1 Manzano Espinosa, Luis
AB Objective: We aimed to test the non-inferiority of oral versus intravenous hydration in the incidence of contrast-associated acute kidney injury (CA-AKI) in elderly outpatients undergoing a contrast-enhanced computed tomography (CE-CT) scan. Methods: PNIC-Na (NCT03476460) is a phase-2, single-center, randomized, open-label, non-inferiority trial. We included outpatients undergoing a CE-CT scan, >65 years having at least one risk factor for CA-AKI, such as diabetes, heart failure, or an estimated glomerular filtration rate (eGFR) of 30–59 mL/min/1.73 m². Participants were randomized (1:1) to oral sodium-chloride capsules or intravenous hydration. The primary outcome was an increase in serum creatinine >0.3 mg/dL or a reduction in eGFR >25% within 48 h. The non-inferiority margin was set at 5%. Results: A total of 271 subjects (mean age 74 years, 66% male) were randomized, and 252 were considered for the main analysis (per-protocol). A total of 123 received oral hydration and 129 intravenous. CA-AKI occurred in 9 (3.6%) of 252 patients and 5/123 (4.1%) in the oral-hydration group vs. 4/129 (3.1%) in the intravenous-hydration group. The absolute difference between the groups was 1.0% (95% CI −4.8% to 7.0%), and the upper limit of the 95% CI exceeded the pre-established non-inferiority margin. No major safety concerns were observed.Conclusion: The incidence of CA-AKI was lower than expected. Although both regimens showed similar incidences of CA-AKI, the non-inferiority was not shown.
PB MDPI
YR 2023
FD 2023-04-19
LK https://hdl.handle.net/20.500.14352/103773
UL https://hdl.handle.net/20.500.14352/103773
LA eng
NO Suárez Carantoña C, Escobar Cervantes C, Fabregate M, López Rodríguez M, Bara Ledesma N, Soto Pérez-Olivares J, et al. Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial. JCM 2023;12:2965. https://doi.org/10.3390/jcm12082965.
NO Descuentos MDPI 2023
NO Ministerio de Sanidad (España)
NO Instituto de Salud Carlos III
DS Docta Complutense
RD 21 abr 2025