Real-time Early Detection of Nephrotoxicity by Accurate and Faster Urinary Biomarker Analysis With SeroFlow Technology (RenaFAST Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Presence of an Acute kidney injury (AKI) event
研究概览
简要总结
The study aims to perform real-time validation of the RenaFAST kit (a point-of-care test kit that quantifies three urinary proteins) in predicting acute kidney injury(AKI) among patients prescribed drug therapies of nephrotoxic potential. Based on the type and duration of drug therapy, a maximum of 5 time-point urine samples will be collected from consenting patients and a real-time biomarker analysis will be conducted using the RenaFAST kits.
详细描述
All eligible patients who fulfill the inclusion and exclusion criteria will be approached for consent. The patients with the highest AKI risk (with all 3 urine biomarkers, Clusterin, monocyte chemoattractant protein-1 (MCP1), and Beta-2 microglobulin (ß2MG), above prediction threshold set by the study) will be identified. The nephrology consultants within the research team will perform a medical chart and physical review(where required) of these patients, noting potential actions to be taken in data collection forms. This will help in evaluating if indeed there are perceived interventions that could potentially be delivered in response to early prediction of AKI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive a projected ≥7 days of therapy of antimicrobials including aminoglycosides (i.e., gentamicin or amikacin), vancomycin, polymyxin, amphotericin and foscarnet.
- •Patients who receive a projected ≥7 days of Calcineurin inhibitors (cyclosporin, tacrolimus)
- •Patients who receive a projected ≥7 days of anti-virals (Cidofovir and Ganciclovir)
- •Patients who receive Anti-cancer drugs (Chemotherapy such as cisplatin, Ifosfamide, Methotrexate, Pemetrexed) or
- •Patients who receive Anti-cancer drugs (Immunotherapy such as immune checkpoint inhibitors as well as types of VGEF inhibitors that are associated with acute kidney injury)
排除标准
- •Patients with AKI prior to therapy initiation.
- •Patients with baseline eGFR < 15 mL/min/1.73m2 (stage 5 chronic kidney disease)
- •Patients admitted to intensive care unit at study baseline, as critical illness is a natural confounder to AKI
- •Females who are pregnant
- •Immediate post-kidney transplant recipients (initial 3 months following transplant).
结局指标
主要结局
Presence of an Acute kidney injury (AKI) event
时间窗: Start date of drug therapy till one week post end date of drug therapy
AKI will be defined by the minimum stage 1 criterion in accordance to KDIGO AKI criteria: 1. Relative increase in serum creatinine of 1.5 times or higher, versus the baseline. 2. Absolute increase in serum creatinine of \> 26.5 μmol/L within 48 hours. Additionally, for those administered cisplatin, cases of severe hyponatremia needing hospitalization for severe dehydration and intravenous fluid-rescue will also be taken as an outcome measure of clinically-evident kidney injury and renal salt wasting. If the subject meets any one of the above 3 criteria, the patient will be recorded as having suffered an AKI event.
次要结局
- Number of patients requiring dialysis treatment for the AKI event(From the date of AKI onset to date of resolution of AKI)
- Severity of AKI event(From the date of AKI onset to date of peak AKI)
- Number of AKI days till recovery(From the date of AKI onset to date of resolution of AKI)
- Length of stay in hospital(From the date of admission to the date of discharge of patient from hospital, assessed up to 12months from date of consent)