Critical Illness
Conditions
Keywords
Acute kidney injury, Continuous renal replacement therapy, Citrate, Heparin
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Oxford
Guy's and St Thomas' NHS Foundation Trust
Oxford University Hospitals NHS Trust
Royal Surrey County Hospital NHS Foundation Trust
University of Bristol
Intensive Care National Audit & Research Centre
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Pre-existing end-stage renal disease (ESRD) * Admitted to an ICU after kidney or kidney-pancreas transplantation * Primary admission with acute hepatic failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 90-days | All-cause mortality 90 days after first ICU admission in which CRRT was received |
| Incremental net monetary benefit | 1-year | Incremental net monetary benefit gained at one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding and thromboembolic episodes | During index admission | Occurrence of bleeding and thromboembolic episodes |
| ICU and hospital length of stay | Up to 5 years | Length of stay in hospital and ICU |
| All-cause mortality | 30-days, and 1-year after ICU admission | All-cause mortality at hospital discharge, 30 days and one year after ICU admission |
| Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT | at 5 years | Lifetime Incremental net monetary benefit gained |
| Dialysis-dependent renal disease | 1-year | Identification of new dialysis-dependent renal disease at 1-year assessed by data linkage with UK Renal Registry |
| Days of renal, cardiovascular, and advanced respiratory support whilst in ICU | Up to 5 years | Total number of days receiving renal, cardiovascular, and advanced respiratory support |
Countries
United Kingdom
Outcome results
None listed