Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06369064

Comparison of Continuous Veno-venous Hemodialysis and Hemodiafiltration on Urea Reduction in Intensive Care Patients with Acute Kidney Injury

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-05-18

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute Kidney Injury (AKI) affects over half of patients in intensive care units (ICUs), with many requiring renal replacement therapy (RRT). This research compares two continuous RRT methods used in ICUs: continuous venovenous hemodialysis (CVVHD) and continuous venovenous hemodiafiltration (CVVHDF). The study aims to determine if CVVHD using citrate anticoagulation is as effective as CVVHDF with heparin in reducing urea levels and maintaining stable clearance, which could improve antibiotic management during treatment. Patients in the study will be randomly assigned to receive either CVVHD or CVVHDF. Both treatments use the same dialysis dose of 25 ml/kg/h and the same type of filter. CVVHD administration involves regional citrate anticoagulation, while CVVHDF uses systemic heparin anticoagulation. Treatments will be delivered using Fresenius Medical Care multiFiltrate PRO kits with Ultraflux AV1000S filters, ensuring consistency in equipment. Participants will be monitored closely with measurements including urea reduction rate at 24 hours as the main outcome. Additional evaluations include creatinine and urea clearance at 24 and 48 hours, mortality rates, organ failure-free days, electrolyte imbalances, and medical costs. The study involves adult ICU patients with AKI stage 3 undergoing their first RRT session, with follow-up continuing through ICU discharge and day 28. The trial is open-label and controlled to assess treatment efficiency and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients hospitalized in an intensive care unit
  • Diagnosis of acute kidney injury stage 3 requiring renal replacement therapy
  • At least one of the following: pH below 7.20, blood urea above 30 mM, uncontrolled fluid overload with specific blood gas criteria, or oliguria lasting 72 hours or more
  • Undergoing their first extracorporeal blood purification session started less than 12 hours before randomization
  • Provided free and informed consent or included in an emergency situation
  • Affiliated with Social Security
Not Eligible

You will not qualify if you...

  • End-stage chronic kidney disease requiring dialysis
  • Intoxication with dialyzable toxins such as lithium
  • Emergency dialysis criteria including hyperkalemia above 6.5 mM with ECG changes
  • Severe liver failure contraindicating regional citrate anticoagulation
  • Medical contraindications to anticoagulation or heparin, including heparin-induced thrombocytopenia or uncontrolled bleeding
  • Pregnant, birthing, or breastfeeding women

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Treatment duration varies based on patient condition and clinical decisions

Participants receive continuous renal replacement therapy using either continuous venovenous hemodialysis (CVVHD) with regional citrate anticoagulation or continuous venovenous hemodiafiltration (CVVHDF) with systemic heparin anticoagulation to treat acute kidney injury.

Continuous therapy with monitoring during ICU stay

Follow-up

Duration - Up to 28 days after treatment starts

Participants are monitored for clinical outcomes including kidney function, mortality, and electrolyte levels up to 28 days after treatment initiation.

Visits and assessments during ICU stay and up to Day 28

Trial Site Locations

Total: 1 location

1

CHU de Nimes

Nîmes, France, 30029

Actively Recruiting

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Research Team

C

Claire Roger, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial.

Olivier Joannes-Boyau, Patrick M Honoré, Paul Perez...

https://pubmed.ncbi.nlm.nih.gov/23740278

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).

Christophe Vinsonneau, Emma Allain-Launay, Clarisse Blayau...

https://pubmed.ncbi.nlm.nih.gov/26714808

Optimization of the treatment with beta-lactam antibiotics in critically ill patients-guidelines from the French Society of Pharmacology and Therapeutics (Société Française de Pharmacologie et Thérapeutique-SFPT) and the French Society of Anaesthesia and Intensive Care Medicine (Société Française d'Anesthésie et Réanimation-SFAR).

Romain Guilhaumou, Sihem Benaboud, Youssef Bennis...

https://pubmed.ncbi.nlm.nih.gov/30925922

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.

Alexander Zarbock, Mira Küllmar, Detlef Kindgen-Milles...

https://pubmed.ncbi.nlm.nih.gov/33095849