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

NCT ID: NCT04215965

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-02
• Study Completion Date: 2022-08-01

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

Conditions

Critical Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Standard citrate protocol

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.

Group Type: EXPERIMENTAL

Biphozyl (dialysate and replacement)

Intervention Type: DRUG

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

Conventionnal citrate protocol

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.

Group Type: ACTIVE_COMPARATOR

Prismocal B22 (dialysate) + phoxilium (replacement)

Intervention Type: DRUG

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

Interventions

Biphozyl (dialysate and replacement)

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

Intervention Type: DRUG

Prismocal B22 (dialysate) + phoxilium (replacement)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie GARRIDO

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Central Contacts

Lionel VELLY, MD/PhD

Role: CONTACT

lionel.velly@ap-hm.fr

Other Identifiers

2019-52

Identifier Type: -

Identifier Source: org_study_id