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Suárez Carantoña, Cecilia; Escobar Cervantes, Carlos; Fabregate, 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, Pau; Liaño, Fernando; Manzano, Luis
Journal of clinical medicine, 04/2023, Letnik: 12, Številka: 8Journal Article
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. 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%. 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. 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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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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