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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04215965

Acronym

Phosphorus

Enrollment

100

Registered

2020-01-02

Start date

2020-05-02

Completion date

2022-08-01

Last updated

2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care

Keywords

CRRT, Renal failure, Citrate, Phosphore

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

Interventions

DRUGBiphozyl (dialysate and replacement)

Replacement solution with phosphate and without calcium in CRRT with citratre-based antigoagulation

DRUGPrismocal B22 (dialysate) + phoxilium (replacement)

solution with phosphate and calcium in CRRT with citratre-based antigoagulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Circuit lifetime	First 3 days of continous renal replacempent therapy	Number of minutes lifespan circuit

Secondary

Measure	Time frame	Description
Efficacy of the new RCA solution	first 3 days of CRRT	Mean daily delivered RRT dose during the first 3 days of CRRT in ml/kg/h between two groups

Contacts

Primary ContactLionel VELLY, MD/PhD

lionel.velly@ap-hm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026