%0 Journal Article
%A Suárez Carantoña, Cecilia
%A Escobar Cervantes, Carlos
%A Fabregate Fuente, Martín
%A López Rodríguez, Mónica
%A Bara Ledesma, Nuria
%A Soto Pérez-Olivares, Javier
%A Ruiz Ortega, Raúl Antonio
%A López Castellanos, Genoveva
%A Olavarría Delgado, Andreina
%A Blázquez Sánchez, Javier
%A Gómez del Olmo, Vicente
%A Moralejo Martín, Myriam
%A Pumares Álvarez, María Belén
%A Sánchez Gallego, María De La Concepción
%A Llàcer Iborra, Pau
%A Liaño García, Fernando
%A Manzano Espinosa, Luis
%T Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial
%D 2023
%U https://hdl.handle.net/20.500.14352/103773
%X 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.
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