Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits
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ClinicalTrials.gov Identifier: NCT04024007 |
Recruitment Status :
Recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
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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.
Condition or disease | Intervention/treatment |
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Dialysis | Diagnostic Test: Citrate dosage |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits |
Estimated Study Start Date : | September 1, 2019 |
Estimated Primary Completion Date : | September 1, 2023 |
Estimated Study Completion Date : | September 1, 2023 |

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.
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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. |
- Citrate concentration - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Citrate concentration in a blood sample taken before the dialysis filter
- Citrate concentration - post-filter [ Time Frame: 30 minutes after the start of dialysis ]Citrate concentration in a blood sample taken after the dialysis filter
- Citrate concentration - dialysate [ Time Frame: 30 minutes after the start of dialysis ]Citrate concentration in a blood sample taken in the dialysate
- Age [ Time Frame: Baseline ]Age
- Weight [ Time Frame: Baseline ]Weight
- Height [ Time Frame: Baseline ]Height
- Sex [ Time Frame: Baseline ]Sex
- Apache II score [ Time Frame: Baseline ]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.
- SOFA (Sequential Organ Failure Assessment) score [ Time Frame: Baseline ]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.
- Glomerular filtration rate (GFR) [ Time Frame: Baseline ]Glomerular filtration rate
- Creatinin level [ Time Frame: Baseline ]Creatinin level
- Diuresis [ Time Frame: Baseline ]Volume of urinary secretion in the last 12 hours
- KDIGO classification [ Time Frame: Baseline ]The KDIGO classification defines 3 stages of increasing severity for acute kidney injuries.
- Na (sodium) concentration -pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Na (sodium) concentration in a blood sample taken before the dialysis filter
- Na (sodium) concentration -post-filter [ Time Frame: 30 minutes after the start of dialysis ]Na (sodium) concentration in a blood sample taken after the dialysis filter
- Cl (chlorine) concentration - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Cl (chlorine) concentration in a blood sample taken before the dialysis filter
- Cl (chlorine) concentration -post-filter [ Time Frame: 30 minutes after the start of dialysis ]Cl (chlorine) concentration in a blood sample taken after the dialysis filter
- K (potassium) concentration - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]K (potassium) concentration in a blood sample taken before the dialysis filter
- K (potassium) concentration - post-filter [ Time Frame: 30 minutes after the start of dialysis ]K (potassium) concentration in a blood sample taken after the dialysis filter
- Total Ca (calcium) concentration -pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Ca (calcium) concentration in a blood sample taken before the dialysis filter
- Total Ca (calcium) concentration -post-filter [ Time Frame: 30 minutes after the start of dialysis ]Ca (calcium) concentration in a blood sample taken after the dialysis filter
- Total Ca (calcium) concentration -dialysate [ Time Frame: 30 minutes after the start of dialysis ]Ca (calcium) concentration in the dialysate
- Ionized calcium (Ca2+) concentration -pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Ca (calcium) concentration in a blood sample taken before the dialysis filter
- Ionized calcium (Ca2+) concentration -post-filter [ Time Frame: 30 minutes after the start of dialysis ]Ca (calcium) concentration in a blood sample taken after the dialysis filter
- Ionized calcium (Ca2+) concentration -dialysate [ Time Frame: 30 minutes after the start of dialysis ]Ca (calcium) concentration in the dialysate
- Mg (magnesium) concentration - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Mg (magnesium) concentration in a blood sample taken before the dialysis filter
- Mg (magnesium) concentration - post-filter [ Time Frame: 30 minutes after the start of dialysis ]Mg (magnesium) concentration in a blood sample taken after the dialysis filter
- PO4 (phosphate) concentration - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]PO4 (phosphate) concentration in a blood sample taken before the dialysis filter
- PO4 (phosphate) concentration - post-filter [ Time Frame: 30 minutes after the start of dialysis ]PO4 (phosphate) concentration in a blood sample taken after the dialysis filter
- Lactate concentration - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Lactate blood concentration in a blood sample taken before the dialysis filter
- Lactate concentration - post-filter [ Time Frame: 30 minutes after the start of dialysis ]Lactate blood concentration in a blood sample taken after the dialysis filter
- Albumin concentration -pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Albumin concentration in a blood sample taken before the dialysis filter
- Albumin concentration -post-filter [ Time Frame: 30 minutes after the start of dialysis ]Albumin concentration in a blood sample taken after the dialysis filter
- pH - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]pH of a blood sample taken before the dialysis filter
- pH - post-filter [ Time Frame: 30 minutes after the start of dialysis ]pH of a blood sample taken after the dialysis filter
- Total C-reactive protein (CRP) -pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Total CRP concentration in a blood sample taken before the dialysis filter
- Total C-reactive protein (CRP) -post-filter [ Time Frame: 30 minutes after the start of dialysis ]Total CRP concentration in a blood sample taken after the dialysis filter
- Total C-reactive protein (CRP) -dialysate [ Time Frame: 30 minutes after the start of dialysis ]Total CRP concentration in a blood sample taken in the dialysate
- Monomeric C-reactive protein (CRP) -pre-filter [ Time Frame: 30 minutes after the start of dialysis ]Monomeric CRP concentration in a blood sample taken before the dialysis filter
- Monomeric C-reactive protein (CRP) -post-filter [ Time Frame: 30 minutes after the start of dialysis ]Monomeric CRP concentration in a blood sample taken after the dialysis filter
- Monomeric C-reactive protein (CRP) -dialysate [ Time Frame: 30 minutes after the start of dialysis ]Monomeric CRP concentration in a blood sample taken in the dialysate

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Intensive care dialysis patients (Continuous Venous Hemofiltration with citrate).
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024007
Contact: Sébastien Redant, MD | 3224773100 | Sebastien.REDANT@chu-brugmann.be |
Belgium | |
CHU Brugmann | Recruiting |
Brussels, Belgium, 1020 | |
Contact: David De Bels, MD 3224779127 David.DEBELS@chu-brugmann.be |
Principal Investigator: | Sébastien Redant, MD | CHU Brugmann |
Responsible Party: | Dr David DE BELS, Head of intensive care unit, Brugmann University Hospital |
ClinicalTrials.gov Identifier: | NCT04024007 History of Changes |
Other Study ID Numbers: |
CHUB-citrate |
First Posted: | July 18, 2019 Key Record Dates |
Last Update Posted: | July 18, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Citric Acid Sodium Citrate Anticoagulants Calcium Chelating Agents |
Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |