Renal Replacement Anticoagulant Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Renal Replacement Anticoagulant Management

Conditions
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Critical Illness

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regional citrate anticoagulation (RCA)<br>Those receiving regional citrate anticoagulation for CRRT | |
| Systemic heparin anticoagulation (SHA)<br>Those receiving systemic heparin anticoagulation for CRRT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality 90 days after first ICU admission in which CRRT was received | 90-days | 
| Incremental net monetary benefit | Incremental net monetary benefit gained at one year | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality at hospital discharge, 30 days and one year after ICU admission | 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 | Up to 5 years | 
| Bleeding and thromboembolic episodes | Occurrence of bleeding and thromboembolic episodes | During index admission | 
| ICU and hospital length of stay | Length of stay in hospital and ICU | 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 | 1-year | 
| Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT | Lifetime Incremental net monetary benefit gained | at 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, Continuous renal replacement therapy, Citrate, Heparin