Renal Replacement Anticoagulant Management

• Conditions: Critical Illness

• Registration Number: NCT03545750
• Lead Sponsor: Intensive Care National Audit & Research Centre

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.

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-04
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Bleeding and thromboembolic episodes	During index admission	Occurrence of bleeding and thromboembolic episodes
Dialysis-dependent renal disease	1-year	Identification of new dialysis-dependent renal disease at 1-year assessed by data linkage with UK Renal Registry
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
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
ICU and hospital length of stay	Up to 5 years	Length of stay in hospital and ICU

Trial Locations

Locations (1)

Intensive Care National Audit and Research Centre; 🇬🇧 London, United Kingdom