Renal Replacement Anticoagulant Management
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 85,000
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Observational comparative effectiveness study of individual patient data using interrupted time series analysis techniques of linked data sources to establish clinical and health economic effects of moving from systemic heparin anticoagulation to regional citrate anticoagulation during continuous renal replacement therapy (CRRT) for patients treated on non-specialist Intensive Care Units (ICUs) in England and Wales.
详细描述
RRAM is an observational comparative effectiveness and cost-effectiveness study of individual patient data using interrupted time series analysis techniques and linked data sources. This study will use existing high quality clinical data collected for the Case Mix programme (CMP) - the national clinical audit for adult critical care - linked with Hospital Episodes Statistics, Office for National Statistics, and UK Renal Registry national data sets to establish the clinical and health economic effects of moving from systemic heparin anticoagulation (SHA) to regional citrate anticoagulation (RCA) during CRRT for patients treated on non-specialist ICUs in England and Wales. This will include data from approximately 85,000 patients treated with CRRT between 1 April 2009 and 31 March 2017 in 184 English non-specialist intensive care units within the ICNARC CMP.
Specific objectives of the RRAM are to:
- Investigate the short-term benefits, risks, and costs of citrate anticoagulation.
- Provide information on the subsequent development of end-stage renal disease (ESRD).
- Trial the efficient research techniques, that if successful could be used to track the effects of any change in critical care practice occurring in ICUs in England and Wales over a reasonably short time scale.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 years or greater
- •Admitted to an ICU participating in the ICNARC Case Mix Programme (CMP) in England between 1 April 2009 and 31st March 2017
排除标准
- •Pre-existing end-stage renal disease (ESRD)
- •Admitted to an ICU after kidney or kidney-pancreas transplantation
- •Primary admission with acute hepatic failure
结局指标
主要结局
All-cause mortality
时间窗: 90-days
All-cause mortality 90 days after first ICU admission in which CRRT was received
Incremental net monetary benefit
时间窗: 1-year
Incremental net monetary benefit gained at one year
次要结局
- All-cause mortality(30-days, and 1-year after ICU admission)
- Bleeding and thromboembolic episodes(During index admission)
- Dialysis-dependent renal disease(1-year)
- Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT(at 5 years)
- Days of renal, cardiovascular, and advanced respiratory support whilst in ICU(Up to 5 years)
- ICU and hospital length of stay(Up to 5 years)