Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CVVHD Dialysis parameters

    Other intervention

    Patients 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 intervention

    Patients 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

80 Participants
are divided into 2 treatment groups
Group A: CVVHDExperimental treatment 1 intervention
Group B: CVVHDFActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours

Secondary outcomes

1

Creatinine clearance at H24

Measured Creatinine clearance at 24 hours (ml/min)

Time frame
24 hours
2

Urea clearance at H24

Measured Urea clearance at 24 hours (ml/min)

Time frame
24 hours
3

Urea clearance at H48

Measured Urea clearance at 48 hours (ml/min)

Time frame
48 hours
4

ICU Mortality

Number of patients who died while in ICU

Time frame
End of ICU Stay

Other outcomes

Sponsors and contacts

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