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.
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: 1. Investigate the short-term benefits, risks, and costs of citrate anticoagulation. 2. Provide information on the subsequent development of end-stage renal disease (ESRD). 3. 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.
Study Type
OBSERVATIONAL
Enrollment
85,000
Intensive Care National Audit and Research Centre
London, United Kingdom
All-cause mortality
All-cause mortality 90 days after first ICU admission in which CRRT was received
Time frame: 90-days
Incremental net monetary benefit
Incremental net monetary benefit gained at one year
Time frame: 1-year
All-cause mortality
All-cause mortality at hospital discharge, 30 days and one year after ICU admission
Time frame: 30-days, and 1-year after ICU admission
Days of renal, cardiovascular, and advanced respiratory support whilst in ICU
Total number of days receiving renal, cardiovascular, and advanced respiratory support
Time frame: Up to 5 years
Bleeding and thromboembolic episodes
Occurrence of bleeding and thromboembolic episodes
Time frame: During index admission
ICU and hospital length of stay
Length of stay in hospital and ICU
Time frame: Up to 5 years
Dialysis-dependent renal disease
Identification of new dialysis-dependent renal disease at 1-year assessed by data linkage with UK Renal Registry
Time frame: 1-year
Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT
Lifetime Incremental net monetary benefit gained
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Time frame: at 5 years