Clinical trial NCT03545750: Renal Replacement Anticoagulant Management
Official title: Renal Replacement Anticoagulant Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Keywords: Acute kidney injury
Continuous renal replacement therapy
Citrate
Heparin
Lead sponsor: Intensive Care National Audit & Research Centre
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Guy's and St Thomas' NHS Foundation Trust
name: Oxford University Hospitals NHS Trust
name: Royal Surrey County Hospital NHS Foundation Trust
name: University of Bristol
First posted: 2018-06-04
Enrollment: 85000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill adults who received CRRT on one or more day whilst treated on an ICU

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: 90-days
measure: Incremental net monetary benefit
timeFrame: 1-year
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30-days, and 1-year after ICU admission
measure: Days of renal, cardiovascular, and advanced respiratory support whilst in ICU
timeFrame: Up to 5 years
measure: Bleeding and thromboembolic episodes
timeFrame: During index admission
measure: ICU and hospital length of stay
timeFrame: Up to 5 years
measure: Dialysis-dependent renal disease
timeFrame: 1-year
measure: Estimated lifetime incremental net benefit associated with a change from heparin to citrate anticoagulation during CRRT
timeFrame: at 5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Intensive Care National Audit and Research Centre
Study officials:
affiliation: University of Oxford
name: Peter Watkinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gould DW, Doidge J, Zia Sadique M, Borthwick M, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Mouncey PR, Ostermann M, Harrison DA, Rowan KM, Duncan Young J, Watkinson PJ. Renal replacement anticoagulant management: Protocol and analysis plan for an observational comparative effectiveness study of linked data sources. J Intensive Care Soc. 2022 Aug;23(3):311-317. doi: 10.1177/1751143720913417. Epub 2020 Apr 2.
citation: Gould DW, Doidge J, Sadique MZ, Borthwick M, Hatch R, Caskey FJ, Forni L, Lawrence RF, MacEwen C, Ostermann M, Mouncey PR, Harrison DA, Rowan KM, Young JD, Watkinson PJ. Heparin versus citrate anticoagulation for continuous renal replacement therapy in intensive care: the RRAM observational study. Health Technol Assess. 2022 Feb;26(13):1-58. doi: 10.3310/ZXHI9396.