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
Internal Medicine Department, Hospital Universitario Ramón y Cajal, IRYCIS, CTRA M-607 Colmenar Viejo, Km 9.10, 28034 Madrid, Spain.
Faculty of Medicine and Health Sciences, Universidad de Alcalá (UAH), Pl. de San Diego, s/n, 28801 Alcalá de Henares, Spain.
J Clin Med. 2023 Apr 19;12(8):2965. doi: 10.3390/jcm12082965.
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.
我们旨在测试在接受增强计算机断层扫描（CE-CT）的老年门诊患者中，口服补液与静脉补液在对比剂相关急性肾损伤（CA-AKI）发生率方面的非劣效性。
PNIC-Na（NCT03476460）是一项2期、单中心、随机、开放标签的非劣效性试验。我们纳入了接受CE-CT扫描的门诊患者，年龄>65岁，至少有一项CA-AKI风险因素，如糖尿病、心力衰竭或估计肾小球滤过率（eGFR）为30-59 mL/min/1.73 m²。参与者被随机（1:1）分为口服氯化钠胶囊组或静脉补液组。主要结局是48小时内血清肌酐升高>0.3 mg/dL或eGFR降低>25%。非劣效性界值设定为5%。
共有271名受试者（平均年龄74岁，66%为男性）被随机分组，252名被纳入主要分析（符合方案集）。共有123名接受口服补液，129名接受静脉补液。252例患者中有9例（3.6%）发生CA-AKI，口服补液组为5/123（4.1%），静脉补液组为4/129（3.1%）。两组之间的绝对差异为1.0%（95%CI -4.8%至7.0%），95%CI的上限超过了预先设定的非劣效性界值。未观察到重大安全问题。
CA-AKI的发生率低于预期。虽然两种方案的CA-AKI发生率相似，但未显示出非劣效性。
