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Low-intensity versus medium-intensity continuous renal replacement therapy for critically ill patients (LIMIT) trial:
Tomoko Fujii1,2, Yu Amemiya3, Akira Endo4,5
1Department of Intensive Care, Jikei University Hospital, Tokyo, Japan.
Background:
Severe acute kidney injury in critically ill patients may require continuous renal replacement therapy (CRRT), yet mortality remains high. A standard CRRT intensity is 20-25 mL/kg/hr, because higher doses have not improved outcomes. Excessive treatment may cause harm by removing antibiotics and other essential substances and potentially impairing renal recovery. Observational data suggest that lower-intensity CRRT may be effective, warranting a clinical trial to compare low-versus standard-intensity therapy.
Objective:
The objective of this study was to describe the prespecified protocol and the statistical analysis plan of the low-intensity versus medium-intensity continuous renal replacement therapy for critically Ill patients (LIMIT) trial.
Design Setting Participants And Interventions:
The LIMIT trial is an investigator-initiated, multicentre, open-label, randomised clinical trial, with a target sample size of 400 participants. The trial compares low-intensity CRRT (12 mL/kg/hr) and medium-intensity CRRT (25 mL/kg/hr) in adult patients with acute kidney injury requiring CRRT in the participating intensive care units.
Main Outcome Measures:
The primary outcome is a hierarchical composite of survival and time to successful liberation from RRT through day 28 from randomisation, analysed using a win-ratio. Secondary outcomes include intensive care unit mortality, hospital mortality, dialysis dependence at hospital discharge among survivors, vasopressor-free days at day 28, and ventilator-free days at day 28.
Conclusion:
The LIMIT trial will evaluate the effect of low-intensity CRRT on mortality and time to successful liberation from RRT compared with medium-intensity CRRT in adults with acute kidney injury. Its findings may also inform future research on broader patient-centred and societal implications of CRRT intensity.