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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Unknown; Phase 4

Conditions: Critical Care

Treatments: Drug: Biphozyl (dialysate and replacement); Drug: Prismocal B22 (dialysate) + phoxilium (replacement)

Study type: Interventional

Funder types: Other

Identifiers

NCT04215965

2019-52

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental Standard citrate protocol

Experimental group

Description:

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.

Treatment:

Drug: Biphozyl (dialysate and replacement)

Conventionnal citrate protocol

Active Comparator group

Description:

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.

Treatment:

Drug: Prismocal B22 (dialysate) + phoxilium (replacement)