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

Critical Care Clinical Trial

— Phosphorus  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04215965
• Other study ID #: 2019-52
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: December 2019
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Lionel VELLY, MD/PhD
• Email: lionel.velly[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Care

Intervention

Drug:
• Biphozyl (dialysate and replacement)
Replacement solution with phosphate and without calcium in CRRT with citratre-based antigoagulation
• Prismocal B22 (dialysate) + phoxilium (replacement)
solution with phosphate and calcium in CRRT with citratre-based antigoagulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circuit lifetime	Number of minutes lifespan circuit	First 3 days of continous renal replacempent therapy
Secondary	Efficacy of the new RCA solution	Mean daily delivered RRT dose during the first 3 days of CRRT in ml/kg/h between two groups	first 3 days of CRRT
Secondary	Efficacy of the new RCA solution	Percentage of decreasing urea during CRRT course between two groups	first 3 days of CRRT