Clinical trial NCT04024007: Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits
Official title: Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dialysis
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- None

Primary outcomes:
measure: Citrate concentration - pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Citrate concentration - post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Citrate concentration - dialysate
timeFrame: 30 minutes after the start of dialysis
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Apache II score
timeFrame: Baseline
measure: SOFA (Sequential Organ Failure Assessment) score
timeFrame: Baseline
measure: Glomerular filtration rate (GFR)
timeFrame: Baseline
measure: Creatinin level
timeFrame: Baseline
measure: Diuresis
timeFrame: Baseline
measure: KDIGO classification
timeFrame: Baseline
measure: Na (sodium) concentration -pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Na (sodium) concentration -post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Cl (chlorine) concentration - pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Cl (chlorine) concentration -post-filter
timeFrame: 30 minutes after the start of dialysis
measure: K (potassium) concentration - pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: K (potassium) concentration - post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Total Ca (calcium) concentration -pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Total Ca (calcium) concentration -post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Total Ca (calcium) concentration -dialysate
timeFrame: 30 minutes after the start of dialysis
measure: Ionized calcium (Ca2+) concentration -pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Ionized calcium (Ca2+) concentration -post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Ionized calcium (Ca2+) concentration -dialysate
timeFrame: 30 minutes after the start of dialysis
measure: Mg (magnesium) concentration - pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Mg (magnesium) concentration - post-filter
timeFrame: 30 minutes after the start of dialysis
measure: PO4 (phosphate) concentration - pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: PO4 (phosphate) concentration - post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Lactate concentration - pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Lactate concentration - post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Albumin concentration -pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Albumin concentration -post-filter
timeFrame: 30 minutes after the start of dialysis
measure: pH - pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: pH - post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Total C-reactive protein (CRP) -pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Total C-reactive protein (CRP) -post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Total C-reactive protein (CRP) -dialysate
timeFrame: 30 minutes after the start of dialysis
measure: Monomeric C-reactive protein (CRP) -pre-filter
timeFrame: 30 minutes after the start of dialysis
measure: Monomeric C-reactive protein (CRP) -post-filter
timeFrame: 30 minutes after the start of dialysis
measure: Monomeric C-reactive protein (CRP) -dialysate
timeFrame: 30 minutes after the start of dialysis
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Sébastien Redant, MD
role: PRINCIPAL_INVESTIGATOR
References: