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临床试验/NCT02583945
NCT02583945撤回不适用

Effect of a Kidney Bundle on the Occurence of Postoperative Acute Kidney Injury in Patients at Risk

Wuerzburg University Hospital2 个研究点 分布在 1 个国家开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Incidence of postoperative AKI

研究概览

简要总结

Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a standardized proceeding in hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI in patients at risk after non-cardiac surgery.

详细描述

All patients included in the study will be treated with the KDIGO-bundle (hemodynamic stabilization, avoidance of nephrotoxic substances, normoglycemia and measurement of creatinine in serum and urine output). 12 h, 24h as well as on day 2, 3, 5 and 10 after admission on ICU the occurence of AKI (according to KDIGO) will be assessed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

kidney treatment bundle (KDIGO)

Experimental

Consequent postoperative application of a kidney treatment bundle: Protocol based hemodynamic optimization and monitoring, regular screening of creatinine in serum and of urine output, no use of potential nephrotoxic medication and normoglycemia.

干预措施: kidney treatment bundle (KDIGO) (Procedure)

结局指标

主要结局

Incidence of postoperative AKI

时间窗: until day 5 after surgery

AKI according to KDIGO definition

次要结局

  • urine output (total ml)(after 12 hours, on day 2 (in 24hour), 3 (in 24hour), 5 (in 24hour) and 10 (in 24hour) after surgery)
  • length of hospital stay(up to 100 days after surgery)
  • length of ICU stay(up to 100 days after surgery)
  • Intensive care unit mortality(28 days and 90 days after surgery)
  • hospital mortality(up to 100 days after surgery)
  • usage of renal replacement therapy (hours)(up to 30 days after surgery)
  • length of invasive respirator therapy (hours)(up to 30 days after surgery)
  • creatinine in serum(12 hours, day 2, 3, 5 and 10 after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Christian Wunder

Vice chair and leading senior physician

Wuerzburg University Hospital

研究点 (2)

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