Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits

NCT04024007 | Unknown

• 1 other identifier: CHUB-citrate
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Citrate anticoagulation is becoming the gold standard in dialysis in intensive care units. It is now accepted that citrate prolongs the life of filters with a lower risk of bleeding. However, the management of citrate is complex. Optimization is based on citrate flow, blood flow and the amount of calcium reinjected. Frequently the citrate level is sub-dosed.Currently, the fraction of excretion of citrate by the hemodialysis machine is unknown. Knowing this information would allow, if it is important enough, to add an additional parameter of citrate management by adapting the level of dialysis. The determination of citrate in an extracorporeal circulation circuit has already been performed and has been validated in the literature. We propose to perform the assay on subjects with the same starting parameters, in order to deduce the clearance of citrate.

Conditions

Dialysis

Outcome Measures

Primary Outcomes (3)

• Citrate concentration - pre-filter

  Citrate concentration in a blood sample taken before the dialysis filter

  30 minutes after the start of dialysis

• Citrate concentration - post-filter

  Citrate concentration in a blood sample taken after the dialysis filter

  30 minutes after the start of dialysis

• Citrate concentration - dialysate

  Citrate concentration in a blood sample taken in the dialysate

  30 minutes after the start of dialysis

Secondary Outcomes (38)

• Age

  Baseline

• Weight

  Baseline

• Height

  Baseline

• Sex

  Baseline

• Apache II score

  Baseline

Study Arms (1)

Dialysis patients

Intensive care dialysis patients (Continuous Venous Hemofiltration with citrate). Dialysis performed according to the standard indications of the service. Patients are dialysed with the prismaflex system on AN69ST membranes.

Diagnostic Test: Citrate dosage

Interventions

Citrate dosage DIAGNOSTIC_TEST

Patients are dialysed according to the standard of care. Biological variables are measured in pre-filter, post-filter and dialysate 30 minutes after the dialysis is initiated.

Dialysis patients

Eligibility Criteria

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

Study Population

Intensive care dialysis patients (Continuous Venous Hemofiltration with citrate). Dialysis performed according to the standard indications of the service. Patients are dialysed with the prismaflex system on AN69ST membranes.

You may qualify if:

• \- Intensive care dialysis patients (Continuous Venous Hemofiltration with citrate).

You may not qualify if:

• \- None

Sponsors & Collaborators

• Dr David DE BELS: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

Study Officials

• Sébastien Redant, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien Redant, MD

CONTACT

3224773100; Sebastien.REDANT@chu-brugmann.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of intensive care unit

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)