About this trial
In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).
To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).
In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.
The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients hospitalized in ICU
Undergo RRT session because of AKI stage 3
At least one among criteria: pH < 7,20 / Blood urea > 30mM / Fluid overload uncontrolled by with PaCO₂ < 35 mmHg or mixed acidosis with PaCO₂ < 50 mmHg.
Oliguria lasting 72 hours or longer
Disqualifiers
End-stage chronic kidney disease on dialysis
Intoxication with a dialyzable toxin (lithium
Criteria for emergency dialysis initiation: hyperkaliemia >6,5mM with electrocardiographic signs
Medical contraindication to regional citrate: severe liver failure
Trial design
Parallel
Treatments tested in this trial
CVVHD Dialysis parameters
Other interventionPatients will receive a CVVHD dialysis with a dose of 25ml/kg/h dialysate (100% dialysate), with Fresenius Medical Care multiFiltrate PRO kit and Ultraflux AV1000S filter (polysuflone 1.8m²).Regional anticoagulation with citrate
CVVHDF Dialysis parameters
Other interventionPatients will receive a CVVHDF dialysis with a dose of 25ml/kg/h dialysate (50% ultrafiltration, 50% dialysate), with Fresenius Medical Care multiFiltrate PRO kit and Ultraflux AV1000S filter (polysuflone 1.8m²). Systemic anticoagulation with heparine
Treatment groups
Trial outcomes
Primary outcomes
urea reduction rate (URR)
The primary endpoint is the rate of urea reduction (TRU) at 24h as a percentage TRU H24 = (urea rate at H0 - urea rate at H24) / urea rate at H0 in each arm.
Secondary outcomes
Creatinine clearance at H24
Measured Creatinine clearance at 24 hours (ml/min)
Urea clearance at H24
Measured Urea clearance at 24 hours (ml/min)
Urea clearance at H48
Measured Urea clearance at 48 hours (ml/min)
ICU Mortality
Number of patients who died while in ICU
Sponsors and contacts
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