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

Acute Kidney Injury Clinical Trial

— CompEER  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369064
• Other study ID #: 2023A02707-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: August 15, 2026

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Claire Roger, MD
• Phone: 04.66.68.30.50
• Email: Claire.roger[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 15, 2026
• Est. primary completion date: August 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Continuous Renal Replacement Therapy
• Intensive Care Unit

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (5)

Guilhaumou R, Benaboud S, Bennis Y, Dahyot-Fizelier C, Dailly E, Gandia P, Goutelle S, Lefeuvre S, Mongardon N, Roger C, Scala-Bertola J, Lemaitre F, Garnier M. Optimization of the treatment with beta-lactam antibiotics in critically ill patients-guidelines from the French Society of Pharmacology and Therapeutics (Societe Francaise de Pharmacologie et Therapeutique-SFPT) and the French Society of Anaesthesia and Intensive Care Medicine (Societe Francaise d'Anesthesie et Reanimation-SFAR). Crit Care. 2019 Mar 29;23(1):104. doi: 10.1186/s13054-019-2378-9. — View Citation

Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11. — View Citation

Joannes-Boyau O, Honore PM, Perez P, Bagshaw SM, Grand H, Canivet JL, Dewitte A, Flamens C, Pujol W, Grandoulier AS, Fleureau C, Jacobs R, Broux C, Floch H, Branchard O, Franck S, Roze H, Collin V, Boer W, Calderon J, Gauche B, Spapen HD, Janvier G, Ouattara A. High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med. 2013 Sep;39(9):1535-46. doi: 10.1007/s00134-013-2967-z. Epub 2013 Jun 6. — View Citation

Vinsonneau C, Allain-Launay E, Blayau C, Darmon M, Ducheyron D, Gaillot T, Honore PM, Javouhey E, Krummel T, Lahoche A, Letacon S, Legrand M, Monchi M, Ridel C, Robert R, Schortgen F, Souweine B, Vaillant P, Velly L, Osman D, Van Vong L. Renal replacement therapy in adult and pediatric intensive care : Recommendations by an expert panel from the French Intensive Care Society (SRLF) with the French Society of Anesthesia Intensive Care (SFAR) French Group for Pediatric Intensive Care Emergencies (GFRUP) the French Dialysis Society (SFD). Ann Intensive Care. 2015 Dec;5(1):58. doi: 10.1186/s13613-015-0093-5. Epub 2015 Dec 30. — View Citation

Zarbock A, Kullmar M, Kindgen-Milles D, Wempe C, Gerss J, Brandenburger T, Dimski T, Tyczynski B, Jahn M, Mulling N, Mehrlander M, Rosenberger P, Marx G, Simon TP, Jaschinski U, Deetjen P, Putensen C, Schewe JC, Kluge S, Jarczak D, Slowinski T, Bodenstein M, Meybohm P, Wirtz S, Moerer O, Kortgen A, Simon P, Bagshaw SM, Kellum JA, Meersch M; RICH Investigators and the Sepnet Trial Group. Effect of Regional Citrate Anticoagulation vs Systemic Heparin Anticoagulation During Continuous Kidney Replacement Therapy on Dialysis Filter Life Span and Mortality Among Critically Ill Patients With Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1629-1639. doi: 10.1001/jama.2020.18618. — View Citation

Outcome

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