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

Phase 4

• Conditions: Critical Care
• Interventions: Drug: Biphozyl (dialysate and replacement); Drug: Prismocal B22 (dialysate) + phoxilium (replacement)

• Registration Number: NCT04215965
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02
• Study Start: 2020-05-02
• Primary Completion: 2021-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Acute renal failure requiring CRRT
2. Suitability for regional anticoagulation of the CRRT circuit
3. Clinical equipoise regarding the method of circuit anticoagulation
4. Subject is affiliated with a social security system (if required by individual country regulations).
5. Subject meets national regulatory criteria for clinical trial participation.
6. Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form

Exclusion Criteria

1. Age less than 18 years
2. Expected stay in ICU less than 24 hours
3. Pregnant or breastfeeding
4. Suspected ischemic hepatitis or liver failure
5. Chronic kidney disease requiring dialysis prior to ICU admission
6. As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person
7. Metformin and acethaminophen intoxication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Standard citrate protocol	Biphozyl (dialysate and replacement)	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.
Conventionnal citrate protocol	Prismocal B22 (dialysate) + phoxilium (replacement)	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.

Primary Outcome Measures

Name	Time	Method
Circuit lifetime	First 3 days of continous renal replacempent therapy	Number of minutes lifespan circuit

Secondary Outcome Measures

Name	Time	Method
Efficacy of the new RCA solution	first 3 days of CRRT	Percentage of decreasing urea during CRRT course between two groups