The Risks of Percutaneous Native Kidney Biopsy in Italy in the Third Millennium: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,304
- 试验地点
- 17
- 主要终点
- Any major post-biopsy complication event
研究概览
简要总结
The estimates risks and benefits of the percutaneous kidney biopsy have been reported mainly from retrospective studies. So far no prospective multicentre studies has been designed to identify rates of biopsy related complications. The aim of this prospective multicentre study was to evaluate safety and complication events related to biopsies on native kidney in Italy.
详细描述
Kidney biopsies performed in 54 italian nephrology centres from 2012 to 2020 were included.
Primary outcome of the study was any major complication, such as haemoglobin decrease more than 2 g/dL, macroematuria, gross ematoma, blood transfusion, artero-venous fistula, invasive intervention, pain, symptomatic hypotension, and/or rapid serum creatinine increase.
Centre and individual patient risk predictors were analysed using multivariate logistic regression analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult or pediatric patients with a kidney disease
- •informed Consent
排除标准
- •patient with a transplanted kidney
结局指标
主要结局
Any major post-biopsy complication event
时间窗: one week follow-up after native kidney biopsy
The cecked of major post-biopsy complication events were clinically relevant hematomas, macrohematuria, decrease of haemoglobin levels after 24 hours \> 2 g /dL, the need for blood transfusion, a large and persistent AV fistula, a post-biopsy anuria, an increase in serum creatinine greater than 50% in the week following biopsy, the need for invasive post-biopsy procedure related to the procedure including nephrectomy, the death related to biopsy
次要结局
未报告次要终点
研究者
Simeone Andrulli, MD
Simeone Andrulli, MD
A. Manzoni Hospital