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临床试验/NCT02827448
NCT02827448已完成不适用

Urinary Cell Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年11月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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