IHD Versus CRRT for Severe Acute Kidney Injury in Critically Ill Patients - Trial NCT06032884

Timeline & Enrollment

Primary Outcome

Major Adverse Kidney Event 90 days after randomization (MAKE90).

Summary

Intermittent hemodialysis (IHD) and continuous RRT (CRRT) provided as continuous
 hemofiltration or hemodiafiltration are the main RRT modalities in ICU. Randomized controlled
 trials (RCTs) comparing IHD and CRRT for AKI have not shown an indisputable benefit of one
 technique over the other. However, these studies were conducted more than 15 years ago. In
 addition, several recent RCTs on RRT initiation strategies have completely modified both
 knowledge and practice of RRT initiation.
 
 The main objective is to evaluate whether IHD is not inferior to CRRT with regard to overall
 incidence of a composite outcome of death, persistent renal dysfunction and dialysis
 dependency at day 90 in critically ill patients with severe AKI (Major Kidney Event 90, MAKE
 90). The primary endpoint will be the proportion of patients who will meet one or more
 criteria for a major adverse kidney event 90 days after randomization (MAKE90). The MAKE will
 be the composite of death, renal replacement therapy dependence and/or an increase in serum
 creatinine above 25% of its basal value.
 
 This is a non-inferiority multicenter open-label randomized controlled trial with two
 parallel groups. Randomization will take place 1:1 to 2 groups: a group receiving IHD and a
 group receiving CRRT. Randomization will be stratified according to center, dose of
 vasopressor and cumulative fluid balance from ICU admission. Treatment will be initiated and
 monitored by the physician responsible for patient. Whatever the group, investigators will
 follow recommendations to achieve optimal metabolic control and hemodynamic stability. The
 investigators plan to include 1000 patients.

ICD-10 Classifications