Division of Nephrology and Hemodialysis, Department of Internal Medicine, Medical University of Graz, Austria.
BMC Nephrol. 2011 Aug 17;12:39. doi: 10.1186/1471-2369-12-39.
Patients with pre-existing impaired renal function are prone to develop acute contrast media induced nephropathy (CIN). Neutrophil gelatinase-associated lipocalin (NGAL), a new biomarker predictive for acute kidney injury (AKI), has been shown to be useful for earlier diagnosis of CIN; however, urinary NGAL values may be markedly increased in chronic renal failure at baseline. Results from those studies suggested that urinary NGAL values may not be helpful for the clinician. An intravenous volume load is a widely accepted prophylactic measure and possibly a reasonable intervention to prevent deterioration of renal function. The aim of our study is to evaluate NGAL as an early predictor of CIN and to investigate the clinical benefit of early post-procedural i.v. hydration.
METHODS/DESIGN: The study will follow a prospective, open-label, randomized controlled design. Patients requiring intra-arterial contrast media (CM) application will be included and receive standardized, weight-based, intravenous hydration before investigation. Subjects with markedly increased urinary NGAL values after CM application will be randomized into one of two study groups. Group A will receive 3-4 ml/kg BW/h 0.9% saline intravenously for 6 hours. Group B will undergo only standard treatment consisting of unrestricted oral fluid intake. The primary outcome measure will be CIN defined by an increase greater than 25% of baseline serum creatinine. Secondary outcomes will include urinary NGAL values, cystatin C values, contrast media associated changes in cardiac parameters such as NT-pro-BNP/troponin T, changes in urinary cytology, need for renal replacement treatment, length of stay in hospital and death.We assume that 20% of the included patients will show a definite rise in urinary NGAL. Prospective statistical power calculations indicate that the study will have 80% statistical power to detect a clinically significant decrease of CIN of 40% in the treatment arm if 1200 patients are recruited into the study.
A volume expansion strategy showing a benefit from earlier intervention for patients with markedly elevated urinary NGAL values, indicating a CIN, might arise from data from this study.
ClinicalTrials.gov NCT01292317.
患有预先存在的肾功能受损的患者易发生急性对比剂诱导的肾病（CIN）。中性粒细胞明胶酶相关脂质运载蛋白（NGAL）是一种新的预测急性肾损伤（AKI）的生物标志物，已被证明可用于 CIN 的早期诊断；然而，在基线时，慢性肾功能衰竭患者的尿 NGAL 值可能会显著升高。这些研究的结果表明，尿 NGAL 值可能对临床医生没有帮助。静脉容量负荷是一种广泛接受的预防措施，可能是防止肾功能恶化的合理干预措施。我们的研究目的是评估 NGAL 作为 CIN 的早期预测指标，并探讨早期术后静脉补液的临床益处。
方法/设计：该研究将采用前瞻性、开放标签、随机对照设计。需要进行动脉内对比剂（CM）应用的患者将被纳入并在检查前接受标准化的、基于体重的静脉补液。CM 应用后尿 NGAL 值显著升高的患者将被随机分为两组。A 组将接受 3-4 ml/kgBW/h 0.9%生理盐水静脉滴注 6 小时。B 组仅接受标准治疗，包括不限量口服补液。主要观察指标为以基线血清肌酐增加大于 25%定义的 CIN。次要结局包括尿 NGAL 值、胱抑素 C 值、CM 相关的 NT-pro-BNP/肌钙蛋白 T 等心脏参数变化、尿细胞学变化、肾脏替代治疗的需要、住院时间和死亡。我们假设纳入的患者中有 20%会出现尿 NGAL 的明显升高。前瞻性统计功效计算表明，如果 1200 例患者入组，该研究将有 80%的统计功效检测出治疗组 CIN 显著下降 40%。
如果从这项研究中获得的数据表明，容量扩张策略对尿 NGAL 值显著升高、表明 CIN 的患者进行早期干预有获益，那么可能会出现这种策略。
ClinicalTrials.gov NCT01292317。
