Renal replacement anticoagulant management: Protocol and analysis plan for an observational comparative effectiveness...

Area of Science:

• Nephrology
• Critical Care Medicine
• Health Services Research

Background:

• Acute kidney injury (AKI) is prevalent in critical illness, often necessitating renal replacement therapy.
• Continuous renal replacement therapy (CRRT) is standard in the UK, requiring anticoagulation.
• Regional citrate anticoagulation (RCA) is replacing heparin for CRRT in UK ICUs without robust evidence.

Purpose of the Study:

• To evaluate the clinical and cost-effectiveness of RCA versus systemic heparin anticoagulation for CRRT.
• To address the safety and longer-term effectiveness of the shift towards RCA in UK intensive care units (ICUs).

Main Methods:

• Observational comparative effectiveness study using existing UK data (2009-2017).
• Analysis of data from ~85,000 patients in adult general ICUs.
• Linked data sources: Case Mix Programme, Civil Registrations, Hospital Episodes Statistics, Patient Episodes Data, UK Renal Registry.
• Includes economic evaluation with micro-costing of anticoagulation strategies.

Main Results:

• Primary outcome: 90-day all-cause mortality.
• Secondary outcomes to be determined from linked datasets.
• Economic evaluation to compare costs of RCA and heparin.

Conclusions:

• The study will provide crucial evidence on the comparative effectiveness and cost-effectiveness of RCA for CRRT.
• Findings will inform clinical practice guidelines and healthcare policy regarding anticoagulation in CRRT.
• Evidence is needed to support the increasing adoption of RCA in critical care settings.