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临床试验/NCT04165369
NCT04165369已完成不适用

Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury

University Hospital Muenster82 个研究点 分布在 13 个国家目标入组 10,568 人开始时间: 2020年6月9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
10,568
试验地点
82
主要终点
Incidence of Acute Kidney Injury

研究概览

简要总结

The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials.

The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.

详细描述

Acute kidney injury (AKI) is a severe clinical complication with increasing incidence and is associated with adverse short- and long-term outcomes resulting in a major health care burden worldwide. The introduction of consensus classification systems has enhanced the awareness for AKI. The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials. However, analyzing AKI from existing databases is often limited by missing data elements, especially the inclusion of the urine output criteria. Missing data and the use of different definitions before the consensus classification are the reasons for large variations in reported occurrences of surgical induced AKI.

The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit (e.g., Intensive Care Unit, Intermediate Care, Post Anesthesia Care Unit) using the latest consensus definition for AKI (Kidney Disease: Improving Global Outcomes criteria) and a standardized data collection instrument and to assess the dependence of AKI on preoperative and intraoperative factors.

Method: International prospective, observational, multi-center, cross-sectional cohort study

Eligible patients will be identified during preoperative assessment. All eligible patients will be approached to obtain written consent.

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

  • major elective or emergency surgery procedures with a duration of at least 2 h
  • admission to the intensive care unit, intermediate care unit after surgery informed consent

排除标准

  • preexisting acute kidney injury
  • acute kidney injury within the last 3 months
  • end stage renal disease with dialysis dependency
  • kidney transplant

结局指标

主要结局

Incidence of Acute Kidney Injury

时间窗: 72 hours after extended surgery

Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria

次要结局

  • Number of patients with renal replacement therapy(up to 90 days after extended surgery)
  • Hospital stay(up to 90 days after extended surgery (until discharge))
  • Intensive Care Unit stay(up to 90 days after extended surgery (until discharge))
  • Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3)(72 hours after extended surgery)
  • Mortality(up to 90 days after extended surgery)
  • Major Adverse Kidney Events (MAKE)(up to 90 days after extended surgery)

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Sponsor

研究点 (82)

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