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NCT Number: NCT06369064

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nimes

Nîmes, 30029, France

Location status: Recruiting

Location contact

Aurèle Buzancais, MD

SUB_INVESTIGATOR

Claire Roger, MD, PhD

CONTACT

[email protected]

Claire Roger, MD, PhD

PRINCIPAL_INVESTIGATOR

Sylvain Garnier, MD

SUB_INVESTIGATOR

About this study

Acute Kidney Injury (AKI) is found in more than 50% of intensive care unit (ICU) patients, with 30% classified as AKI Network (AKIN) stage 3. Approximately 23% of AKI patients undergo RRT, predominantly utilizing continuous techniques due to better hemodynamic tolerance in unstable patients. Common continuous RRT techniques include continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF).

The two most employed techniques in ICU are CVVHDF and CVVHD. However, the choice often depends on institutional practices rather than scientific evidence. Limited studies comparing these techniques at equivalent doses exist, and French recommendations allow intensivists discretion based on availability and team experience. A small, randomized study comparing different exchange rates found higher urea reduction in CVVHDF but lacked statistical significance. Current practices in ICU involve using CVVHDF with systemic anticoagulation or CVVHD with regional citrate anticoagulation based on practitioner preferences.

Despite potential benefits of CVVHD with citrate, such as extended filter lifespan and stable dialysis dose, the impact on concomitant treatments, especially antibiotics, needs consideration.

The study aims to demonstrate the non-inferiority of citrate-based continuous hemodialysis (CVVHD) compared to heparin-based continuous hemodiafiltration (CVVHDF) in terms of urea reduction rate at 24 hours in AKI patients requiring renal replacement therapy.

The hypothesis is that CVVHD citrate is as effective as CVVHDF heparin, providing prolonged and stable clearance, facilitating antibiotic management during RRT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients undergoing their first session of extracorporeal blood purification, initiated less than 12 hours prior to randomization
  • Patient having given free and informed consent, and having signed the consent form or patient included in an emergency situation
  • Patient affiliated with Social Security.

Exclusion criteria

  • 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
  • Medical contraindication to anticoagulation or heparin anticoagulation: heparin induced thrombopenia or uncontrolled bleeding
  • Pregnant women, parturient or breast-feeding patient

Treatment and study plan

CVVHD Dialysis parameters

Other

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

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

Primary outcomes

  1. urea reduction rate (URR)

    Time frame: 24 hours

    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

  1. Creatinine clearance at H24

    Time frame: 24 hours

    Measured Creatinine clearance at 24 hours (ml/min)

  2. Urea clearance at H24

    Time frame: 24 hours

    Measured Urea clearance at 24 hours (ml/min)

  3. Urea clearance at H48

    Time frame: 48 hours

    Measured Urea clearance at 48 hours (ml/min)

  4. ICU Mortality

    Time frame: End of ICU Stay

    Number of patients who died while in ICU

  5. Mortality at Day 28

    Time frame: Day 28

    Number of patients who died betwwen day à and day 28

  6. Organ failure-free days at Day 28

    Time frame: Day 28

    Number of organ failure-free days at Day 28

  7. Hypokalemia at Day 28

    Time frame: Day 28

    Hypokalemia < 3mmol/l occurring between Day 0 and Day 28

  8. Hypophosphatemia at Day 28

    Time frame: Day 28

    Hypophosphatemia < 0.8mmol/l occurring between Day 0 and Day 28

  9. Hypomagnesemia at Day 28

    Time frame: Day 28

    Hypomagnesemia < 0.8mmol/l occurring between Day 0 and Day 28

  10. Hyperkalemia at Day 28

    Time frame: Day 28

    Hyperkalemia >6mmol/l occurring between Day 0 and Day 28

  11. Medical Cost

    Time frame: 24 hours

    Cost of one continuous hemodialysis (CVVHD) session with citrate compared to one continuous hemodiafiltration (CVVHDF)

Study contacts

Contact information is provided by the study sponsor or research team.

Claire Roger, MD

CONTACT

[email protected]

04.66.68.30.50

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Comparison of the Effectiveness of Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patients With Acute Renal Injury : a Monocentric Controled Randomized Non Inferiority Open Labeled Study

Acronym: CompEER

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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