Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient
- Conditions
- Intensive Care UnitContinuous Renal Replacement TherapyAcute Kidney Injury
- Interventions
- Other: CVVHD Dialysis parametersOther: CVVHDF Dialysis parameters
- Registration Number
- NCT06369064
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CVVHD CVVHD Dialysis parameters Patient requiring renal remplacement therapy treated with by continuous venovenous hemodialysis (CVVHD) method. CVVHDF CVVHDF Dialysis parameters Patient requiring renal remplacement therapy treated with by continuous venovenous hemodiafiltration (CVVHDF) method.
- Primary Outcome Measures
Name Time Method urea reduction rate (URR) 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 Outcome Measures
Name Time Method Organ failure-free days at Day 28 Day 28 Number of organ failure-free days at Day 28
Urea clearance at H24 24 hours Measured Urea clearance at 24 hours (ml/min)
Creatinine clearance at H24 24 hours Measured Creatinine clearance at 24 hours (ml/min)
Urea clearance at H48 48 hours Measured Urea clearance at 48 hours (ml/min)
Hypokalemia at Day 28 Day 28 Hypokalemia \< 3mmol/l occurring between Day 0 and Day 28
Hypophosphatemia at Day 28 Day 28 Hypophosphatemia \< 0.8mmol/l occurring between Day 0 and Day 28
ICU Mortality End of ICU Stay Number of patients who died while in ICU
Mortality at Day 28 Day 28 Number of patients who died betwwen day à and day 28
Hypomagnesemia at Day 28 Day 28 Hypomagnesemia \< 0.8mmol/l occurring between Day 0 and Day 28
Hyperkalemia at Day 28 Day 28 Hyperkalemia \>6mmol/l occurring between Day 0 and Day 28
Medical Cost 24 hours Cost of one continuous hemodialysis (CVVHD) session with citrate compared to one continuous hemodiafiltration (CVVHDF)
Trial Locations
- Locations (1)
CHU de Nimes
🇫🇷Nîmes, France