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

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.

Study Overview

• Status: Recruiting
• Conditions: Dialysis
• Intervention / Treatment: Diagnostic test: Citrate dosage

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Sébastien Redant, MD; Phone Number: 3224773100; Email: Sebastien.REDANT@chu-brugmann.be

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • CHU Brugmann
    • Contact: David De Bels, MD; Phone Number: 3224779127; Email: David.DEBELS@chu-brugmann.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age	Baseline
Sex	Sex	Baseline
Weight	Weight	Baseline
Height	Height	Baseline
Apache II score	The APACHE II score is calculated at the beginning of the intensive care unit admission to help determine the patient's mortality risk for the admission. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death.	Baseline
SOFA (Sequential Organ Failure Assessment) score	The Sequential Organ Failure Assessment score (SOFA score), is used in intensive care units to determine and track the status of a patient with organ failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Higher scores mean a higher risk of mortality.	Baseline
Glomerular filtration rate (GFR)	Glomerular filtration rate	Baseline
Creatinin level	Creatinin level	Baseline
Diuresis	Volume of urinary secretion in the last 12 hours	Baseline
KDIGO classification	The KDIGO classification defines 3 stages of increasing severity for acute kidney injuries.	Baseline
Na (sodium) concentration -pre-filter	Na (sodium) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Na (sodium) concentration -post-filter	Na (sodium) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Cl (chlorine) concentration - pre-filter	Cl (chlorine) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Cl (chlorine) concentration -post-filter	Cl (chlorine) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
K (potassium) concentration - pre-filter	K (potassium) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
K (potassium) concentration - post-filter	K (potassium) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Total Ca (calcium) concentration -pre-filter	Ca (calcium) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Total Ca (calcium) concentration -post-filter	Ca (calcium) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Total Ca (calcium) concentration -dialysate	Ca (calcium) concentration in the dialysate	30 minutes after the start of dialysis
Ionized calcium (Ca2+) concentration -pre-filter	Ca (calcium) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Ionized calcium (Ca2+) concentration -post-filter	Ca (calcium) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Ionized calcium (Ca2+) concentration -dialysate	Ca (calcium) concentration in the dialysate	30 minutes after the start of dialysis
Mg (magnesium) concentration - pre-filter	Mg (magnesium) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Mg (magnesium) concentration - post-filter	Mg (magnesium) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
PO4 (phosphate) concentration - pre-filter	PO4 (phosphate) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
PO4 (phosphate) concentration - post-filter	PO4 (phosphate) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Lactate concentration - pre-filter	Lactate blood concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Lactate concentration - post-filter	Lactate blood concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Albumin concentration -pre-filter	Albumin concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Albumin concentration -post-filter	Albumin concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
pH - pre-filter	pH of a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
pH - post-filter	pH of a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Total C-reactive protein (CRP) -pre-filter	Total CRP concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Total C-reactive protein (CRP) -post-filter	Total CRP concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Total C-reactive protein (CRP) -dialysate	Total CRP concentration in a blood sample taken in the dialysate	30 minutes after the start of dialysis
Monomeric C-reactive protein (CRP) -pre-filter	Monomeric CRP concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Monomeric C-reactive protein (CRP) -post-filter	Monomeric CRP concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Monomeric C-reactive protein (CRP) -dialysate	Monomeric CRP concentration in a blood sample taken in the dialysate	30 minutes after the start of dialysis

Collaborators and Investigators

• Sponsor: Dr David DE BELS
• Investigators: Principal Investigator: Sébastien Redant, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CHUB-citrate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No