Acute Kidney Injury, Continuous Renal Replacement Therapy, Intensive Care Unit
Conditions
Keywords
continuous venovenous hemodiafiltration, continuous venovenous hemodialysis, urea reduction rate
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.
Interventions
OTHERCVVHD Dialysis parameters
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
OTHERCVVHDF Dialysis parameters
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
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Creatinine clearance at H24 | 24 hours | Measured Creatinine clearance at 24 hours (ml/min) |
| Urea clearance at H24 | 24 hours | Measured Urea clearance at 24 hours (ml/min) |
| Urea clearance at H48 | 48 hours | Measured Urea clearance at 48 hours (ml/min) |
| 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 |
| Organ failure-free days at Day 28 | Day 28 | Number of organ failure-free days at Day 28 |
| 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 |
| 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) |
Countries
France
Contacts
CONTACTClaire Roger, MD
PRINCIPAL_INVESTIGATORClaire Roger
CHU Nimes
Outcome results
None listed