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

Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04024007
• Other study ID #: CHUB-citrate
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: Brugmann University Hospital
• Contact: Sébastien Redant, MD
• Phone: 3224773100
• Email: Sebastien.REDANT[@]chu-brugmann.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Dialysis

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Dr David DE BELS

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Citrate concentration - pre-filter	Citrate concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Primary	Citrate concentration - post-filter	Citrate concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Primary	Citrate concentration - dialysate	Citrate concentration in a blood sample taken in the dialysate	30 minutes after the start of dialysis
Secondary	Age	Age	Baseline
Secondary	Weight	Weight	Baseline
Secondary	Height	Height	Baseline
Secondary	Sex	Sex	Baseline
Secondary	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
Secondary	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
Secondary	Glomerular filtration rate (GFR)	Glomerular filtration rate	Baseline
Secondary	Creatinin level	Creatinin level	Baseline
Secondary	Diuresis	Volume of urinary secretion in the last 12 hours	Baseline
Secondary	KDIGO classification	The KDIGO classification defines 3 stages of increasing severity for acute kidney injuries.	Baseline
Secondary	Na (sodium) concentration -pre-filter	Na (sodium) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Secondary	Na (sodium) concentration -post-filter	Na (sodium) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Secondary	Cl (chlorine) concentration - pre-filter	Cl (chlorine) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Secondary	Cl (chlorine) concentration -post-filter	Cl (chlorine) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Secondary	K (potassium) concentration - pre-filter	K (potassium) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Secondary	K (potassium) concentration - post-filter	K (potassium) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Secondary	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
Secondary	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
Secondary	Total Ca (calcium) concentration -dialysate	Ca (calcium) concentration in the dialysate	30 minutes after the start of dialysis
Secondary	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
Secondary	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
Secondary	Ionized calcium (Ca2+) concentration -dialysate	Ca (calcium) concentration in the dialysate	30 minutes after the start of dialysis
Secondary	Mg (magnesium) concentration - pre-filter	Mg (magnesium) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Secondary	Mg (magnesium) concentration - post-filter	Mg (magnesium) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Secondary	PO4 (phosphate) concentration - pre-filter	PO4 (phosphate) concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Secondary	PO4 (phosphate) concentration - post-filter	PO4 (phosphate) concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Secondary	Lactate concentration - pre-filter	Lactate blood concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Secondary	Lactate concentration - post-filter	Lactate blood concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Secondary	Albumin concentration -pre-filter	Albumin concentration in a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Secondary	Albumin concentration -post-filter	Albumin concentration in a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Secondary	pH - pre-filter	pH of a blood sample taken before the dialysis filter	30 minutes after the start of dialysis
Secondary	pH - post-filter	pH of a blood sample taken after the dialysis filter	30 minutes after the start of dialysis
Secondary	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
Secondary	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
Secondary	Total C-reactive protein (CRP) -dialysate	Total CRP concentration in a blood sample taken in the dialysate	30 minutes after the start of dialysis
Secondary	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
Secondary	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
Secondary	Monomeric C-reactive protein (CRP) -dialysate	Monomeric CRP concentration in a blood sample taken in the dialysate	30 minutes after the start of dialysis