Renal Replacement Anticoagulant Management (RRAM)

Intensive Care National Audit & Research Centre

Status: Unknown

Conditions: Critical Illness

Study type: Observational

Funder types: Other

Identifiers

NCT03545750

ICNARC/02/08/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85,000 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

85,000 participants in 2 patient groups

Regional citrate anticoagulation (RCA)

Description:

Those receiving regional citrate anticoagulation for CRRT

Systemic heparin anticoagulation (SHA)

Description:

Those receiving systemic heparin anticoagulation for CRRT