Oral Sodium Chloride in the Prevention of Contrast-Associated Acute Kidney Injury in Elderly Outpatients: The PNIC-Na Randomized Non-Inferiority Trial

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...

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Detalles Bibliográficos
Autores: Suárez Carantoña, Cecilia, Escobar Cervantes, Carlos, Fabregate Fuente, Martín, López Rodríguez, Mónica, Bara Ledesma, Nuria, Soto Pérez-Olivares, Javier, Ruiz Ortega, Raúl Antonio, López Castellanos, Genoveva, Olavarría Delgado, Andreina, Blázquez Sánchez, Javier, Gómez del Olmo, Vicente, Moralejo Martín, Myriam, Pumares Álvarez, María Belén, Sánchez Gallego, María De La Concepción, Llàcer Iborra, Pau, Liaño García, Fernando, Manzano Espinosa, Luis
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Universidad Complutense de Madrid (UCM)
Repositorio:Docta Complutense
Idioma:inglés
OAI Identifier:oai:docta.ucm.es:20.500.14352/103773
Acceso en línea:https://hdl.handle.net/20.500.14352/103773
Access Level:acceso abierto
Palabra clave:61
615.07
001.891:61
Contrast-associated acute kidney injury
Contrast-enhanced computed tomography
Elderly
Medicina
24 Ciencias de la Vida
Descripción
Sumario: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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