Efficacy and Safety of a Citrate-based Anticoagulation With Calcium-free Phosphate-containing Fluid in Renal Replacement Therapy

Study Overview
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Brief Summary
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In the present prospective multicenter RCT we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new RCA protocol for Continuous Venovenous Hemodiafiltration (CVVHDF) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as dialysate and replacement fluid. The new protocol will be introduced with the following targets: a) to refine buffers balance of a previously adopted RCA protocol for Continuous Venovenous Hemofiltration (CVVH), based on a 18 mmol/l citrate solution (Regiocit) combined with calcium and phosphate-free dialysate fluid (PrismOcal B22) and a conventional phosphate-containing replacement fluid (Phoxilium) to prevent CRRT-related phosphate depletion

Official Title
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Efficacy and Safety of a Low-citrate-based Anticoagulation With Calcium-free Phosphate-containing Replacement Fluid Compared to Standard Citrate-based Anticoagulation Protocol in Patients Requiring Continuous Renal Replacement Therapy; a Randomized Controlled Trial

Conditions
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Critical Care

Intervention / Treatment
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* Drug: Biphozyl (dialysate and replacement)
* Drug: Prismocal B22 (dialysate) + phoxilium (replacement)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute renal failure requiring CRRT Suitability for regional anticoagulation of the CRRT circuit Clinical equipoise regarding the method of circuit anticoagulation Subject is affiliated with a social security system (if required by individual country regulations). Subject meets national regulatory criteria for clinical trial participation. Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form Exclusion Criteria: Age less than 18 years Expected stay in ICU less than 24 hours Pregnant or breastfeeding Suspected ischemic hepatitis or liver failure Chronic kidney disease requiring dialysis prior to ICU admission As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person Metformin and acethaminophen intoxication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Standard citrate protocol<br>CVVHDF will be performed using Regiocit solution in the predilution mode, Biphozyl in the dialysate and postdilution mode. CRRT will be started at a dose of 35 ml/kg/h. | Drug: Biphozyl (dialysate and replacement)<br>* Replacement solution with phosphate and without calcium in CRRT with citratre-based antigoagulation<br>|
| Active Comparator: Conventionnal citrate protocol<br>CVVHDF will be performed using Regiocit solution in the predilution mode, Prismocal B22 (calcium and phosphate free) in the dialysate mode, and Phoxilium in the postdilution mode. CRRT will be started at a dose of 35 ml/kg/h. | Drug: Prismocal B22 (dialysate) + phoxilium (replacement)<br>* solution with phosphate and calcium in CRRT with citratre-based antigoagulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circuit lifetime | Number of minutes lifespan circuit | First 3 days of continous renal replacempent therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the new RCA solution | Mean daily delivered RRT dose during the first 3 days of CRRT in ml/kg/h between two groups | first 3 days of CRRT | 
| Efficacy of the new RCA solution | Percentage of decreasing urea during CRRT course between two groups | first 3 days of CRRT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRRT, Renal failure, Citrate, Phosphore