Study protocol and statistical plan for the ICRAKI trial: Intermittent haemodialysis versus continuous renal replacement therapy for severe acute kidney injury in critically ill patients.

BACKGROUND

The effect of intermittent haemodialysis (IHD) continuous renal replacement therapy (CRRT) on mortality and/or renal function recovery in adults with acute kidney injury (AKI) and a recognised indication for renal replacement therapy (RRT) remains controversial.

OBJECTIVE

To summarise the protocol and statistical analysis plan for the ICRAKI trial.

DESIGN SETTINGS AND PARTICIPANTS

ICRAKI is a non-inferiority multicentre randomised controlled trial comparing IHD and CRRT. We will include 1000 patients with AKI receiving (or who have received) invasive mechanical ventilation and/or catecholamine infusion and who have at least one recognised criterion for initiating RRT.

INTERVENTION

The study compares IHD with CRRT.

MAIN OUTCOMES MEASURES

The primary endpoint is the proportion of patients who will meet one or more criteria for a major adverse kidney event (composite of death, RRT dependence and/or more than a 25 % increase in serum creatinine from baseline value) 90 days after randomisation. Secondary endpoints are time to death; mortality at day (D)28, D60 and D90; number of patients with RRT dependency at D28, D60 and D90; number of patients with more than a 25 % increase in serum creatinine from baseline value at D28, D60 and D90; intensive care unit (ICU) and hospital length of stay; time until cessation of RRT; catecholamine-free days, ventilator-free days and RRT-free days through day 28; estimated glomerular filtration rate at hospital discharge; the number of episodes of adverse events.

CONCLUSION

The ICRAKI trial will inform the choice of RRT modalities in critically ill patients with severe AKI. More than 300 patients were already included.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT06032884. Date of registration, 2023-09-04.