Urinary Cell Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury Following Advanced Cardiac Replacement Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- [TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation
研究概览
简要总结
The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive laboratory test performed on urine, predicts loss of kidney function in patients that have had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart (TAH) implanted.
详细描述
Current strategies for AKI detection rely primarily on elevations in serum creatinine in conjunction with diminished urine output. Unfortunately, deviations in these crude parameters of renal function are largely insensitive and late manifestations of AKI, where acute tubular necrosis has likely already transpired and therefore well beyond the phase where preventive measures may be instituted. Early phase biomarkers, insulin-like growth factor-binding protein 7 ("IGFBP7") and tissue inhibitor of metalloproteinases-2 ("TIMP-2") are critical mediators of G1 cell cycle arrest of renal tubular cells during the early phase of cellular injury, providing a potential therapeutic window to prevent permanent damage. To date, no study has evaluated the efficacy of these early phase renal biomarkers for detecting AKI in advanced heart failure patients undergoing cardiac replacement therapies.
Therefore, the aim of this prospective observational study will be to evaluate the effectiveness of the NephroCheckTM to predict AKI in patients undergoing transplant, LVAD implant, or TAH implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who will receive LVAD or heart transplantation
排除标准
- •Patients who are unable to give consent
结局指标
主要结局
[TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation
时间窗: 1 year
Occurrence of AKI following LVAD or TAH implantation
时间窗: 1 year
次要结局
- [TIMP-2]*[IGFBP7] measurement using NephroCheck following cardiac transplantation(1 year)
