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