跳至主要内容
临床试验/NCT02730637
NCT02730637已完成不适用

Prevention of Acute Kidney Injury Through Biomarker-guided Nephrological

Robert Bosch Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Incidence of AKI in both groups according to AKI KDIGO definition

研究概览

简要总结

This study examines the clinical relevance of early biomarkers to detect and prevent acute kidney injury. High-risk patients for developing acute kidney injury will be screened at initial presentation (emergency department and intensive care unit) for TIMP2xIGFBP7. In case of elevated readings patients will be randomized in two arms: The control group will be treated with standard care, the intervention group will receive an early nephrologic consultation.

详细描述

This study examines the impact of an early biomarker-guided intervention on the development of acute kidney injury (AKI). New biomarkers indicate kidney damage in an early stage before developing acute kidney injury according to AKI Kidney Disease Improving Global Outcomes (KDIGO) Definition is detectable. The investigators want to test if it's possible to prevent AKI based on elevated urinary biomarkers. Eligible patients will be randomly assigned to two groups, a control and an intervention Group by an early nephrologic consultation. The interventional group will receive an early preventive nephrologist consultation additionally to standard care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • no acute kidney injury stage II-III (according to AKI KDIGO definition)
  • urinary biomarker levels above cut-off
  • inpatient treatment
  • age ≥18 years
  • informed consent or presumed will

排除标准

  • existing acute kidney injury stage II-III (according to AKI KDIGO definition)
  • age < 18 years
  • end stage renal disease (ESRD), existing renal replacement therapy
  • pregnancy
  • withdrawal of consent
  • missing presumed will

研究组 & 干预措施

Standard care

No Intervention

Patients with elevated biomarkers receive a standard treatment.

Interventional care

Active Comparator

Patients in the interventional population receive an early nephrologist consultation which deliberates with attending doctor on preventing measures according to AKI-KDIGO recommendations.

干预措施: Early nephrologist consultation (Other)

结局指标

主要结局

Incidence of AKI in both groups according to AKI KDIGO definition

时间窗: within 24 hours

次要结局

  • Length of hospital stay(within 60 days)
  • Severity of AKI in both groups according to AKI KDIGO definition(within 60 days)
  • Need for renal replacement therapy(within 60 days)
  • Severety of AKI in both groups according to AKI KDIGO definition(within 72 hours)
  • Incidence of AKI in both groups according to AKI KDIGO definition(within 60 days)
  • Death(within 60 days)

研究者

发起方
Robert Bosch Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Martin Kimmel, MD

MD

Robert Bosch Medical Center

研究点 (2)

Loading locations...

相似试验