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临床试验/NCT03989505
NCT03989505已完成不适用

Proenkephalin ANd Creatinine in the Prediction of Cardiac Contrast-Associated Kidney Events

Dr. med. Mahir Karakas1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
220
试验地点
1
主要终点
Sustained kidney injury

研究概览

简要总结

Currently, contrast-induced kidney injury cannot be diagnosed on the day of cardiac catheterization. Recently, proenkephalin (penKid) was introduced as a new glomerular filtration marker. The aim of this study is to investigate whether the change in penKid level allows for early detection of affected patients.

详细描述

Use of contrast media is necessary for diagnostic imaging and percutaneous coronary intervention. However, contrast-induced kidney injury, a complication of contrast use, has been identified as the most frequent cause of hospital-acquired acute kidney injury and is associated with poor prognosis. Currently, contrast-induced kidney injury cannot be diagnosed on the day of cardiac catheterization or on the following day, when the majority of patients who undergo elective cardiac catheterization are discharged from the hospital in the real-world setting. Recently, proenkephalin (penKid) was introduced as a new glomerular filtration marker, which is capable of identifying normal subjects at high risk of future decline in renal function. The aim of this study is to investigate whether the change in penKid level on the day following cardiac catheterization can predict kidney injury before hospital discharge and thus allows for early detection of affected patients.

For this purpose a total of 214 consecutive patients who undergo routine cardiac catherization will be recruited, and blood will be drawn at three time-points: immediately before catherization, 12-24 hours after catheterization and 4-8 weeks after discharge. Creatinine will be measured for endpoint definition, while the markers urea, CRP (C-reactive protein), NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (kidney injury marker-1), cystatin C, suPAR (soluble urokinase-type plasminogen activator receptor), and penKid will be measured as biomarkers of interest. The main outcome measure is sustained kidney injury (SKI), which is defined as an increase above 20% in serum creatinine between time-points 1 and 3. The main test is whether the change in biomarkers between baseline and immediately before discharge (time-points 1 and 2) can predict the development of sustained kidney injury.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years of age
  • Planned elective or urgent coronary or non-coronary angiography with iodinated contrast media
  • Ability to provide informed consent

排除标准

  • Current use of renal replacement therapy/hemodialysis
  • life expectancy < 6 months

结局指标

主要结局

Sustained kidney injury

时间窗: Time period between the two time-points: immediately before catherization and 4-8 weeks after discharge

defined as an increase above 20% in serum creatinine

次要结局

未报告次要终点

研究者

发起方
Dr. med. Mahir Karakas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. med. Mahir Karakas

Coordinating Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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