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

NCT04215965 | Unknown Phase 4 DMC

• 1 other identifier: 2019-52
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

CRRT; Renal failure; Citrate; Phosphore

Outcome Measures

Primary Outcomes (1)

• Circuit lifetime

  Number of minutes lifespan circuit

  First 3 days of continous renal replacempent therapy

Secondary Outcomes (2)

• Efficacy of the new RCA solution

  first 3 days of CRRT

• Efficacy of the new RCA solution

  first 3 days of CRRT

Study Arms (2)

Experimental Standard citrate protocol

EXPERIMENTAL

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)

Conventionnal citrate protocol

ACTIVE COMPARATOR

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)

Interventions

Biphozyl (dialysate and replacement) DRUG

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

Experimental Standard citrate protocol

Prismocal B22 (dialysate) + phoxilium (replacement) DRUG

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

Conventionnal citrate protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Dialysis Solutions; Replantation

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Transplantation; Surgical Procedures, Operative

Study Officials

• Emilie GARRIDO

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

Lionel VELLY, MD/PhD

CONTACT

lionel.velly@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 2, 2020
• Study Start: May 2, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share