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

April 12, 2024 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nîmes, France, 30029
        • Chu de Nimes
        • Contact:
        • Principal Investigator:
          • Claire Roger, MD, PhD
        • Sub-Investigator:
          • Aurèle Buzancais, MD
        • Sub-Investigator:
          • Sylvain Garnier, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 diuretics.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVVHD
Patient requiring renal remplacement therapy treated with by continuous venovenous hemodialysis (CVVHD) method.
Other: CVVHD Dialysis parameters
In the CVVHD group, patients will receive a dialysis 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
Active Comparator: CVVHDF
Patient requiring renal remplacement therapy treated with by continuous venovenous hemodiafiltration (CVVHDF) method.
Other: CVVHDF Dialysis parameters
In the CVVHD group, patients will receive a dialysis 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creatinine clearance at H24
Time Frame: 24 hours
Measured Creatinine clearance at 24 hours (ml/min)
24 hours
Urea clearance at H24
Time Frame: 24 hours
Measured Urea clearance at 24 hours (ml/min)
24 hours
Urea clearance at H48
Time Frame: 48 hours
Measured Urea clearance at 48 hours (ml/min)
48 hours
ICU Mortality
Time Frame: End of ICU Stay
Number of patients who died while in ICU
End of ICU Stay
Mortality at Day 28
Time Frame: Day 28
Number of patients who died betwwen day à and day 28
Day 28
Organ failure-free days at Day 28
Time Frame: Day 28
Number of organ failure-free days at Day 28
Day 28
Hypokalemia at Day 28
Time Frame: Day 28
Hypokalemia < 3mmol/l occurring between Day 0 and Day 28
Day 28
Hypophosphatemia at Day 28
Time Frame: Day 28
Hypophosphatemia < 0.8mmol/l occurring between Day 0 and Day 28
Day 28
Hypomagnesemia at Day 28
Time Frame: Day 28
Hypomagnesemia < 0.8mmol/l occurring between Day 0 and Day 28
Day 28
Hyperkalemia at Day 28
Time Frame: Day 28
Hyperkalemia >6mmol/l occurring between Day 0 and Day 28
Day 28
Medical Cost
Time Frame: 24 hours
Cost of one continuous hemodialysis (CVVHD) session with citrate compared to one continuous hemodiafiltration (CVVHDF)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Claire Roger, Chu Nimes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2024

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023A02707-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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