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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
Sponsor:
Information provided by (Responsible Party):
Dr David DE BELS, Brugmann University Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Dialysis Diagnostic Test: Citrate dosage

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Citrate concentration - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]
    Citrate concentration in a blood sample taken before the dialysis filter

  2. Citrate concentration - post-filter [ Time Frame: 30 minutes after the start of dialysis ]
    Citrate concentration in a blood sample taken after the dialysis filter

  3. Citrate concentration - dialysate [ Time Frame: 30 minutes after the start of dialysis ]
    Citrate concentration in a blood sample taken in the dialysate


Secondary Outcome Measures :
  1. Age [ Time Frame: Baseline ]
    Age

  2. Weight [ Time Frame: Baseline ]
    Weight

  3. Height [ Time Frame: Baseline ]
    Height

  4. Sex [ Time Frame: Baseline ]
    Sex

  5. 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.

  6. 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.

  7. Glomerular filtration rate (GFR) [ Time Frame: Baseline ]
    Glomerular filtration rate

  8. Creatinin level [ Time Frame: Baseline ]
    Creatinin level

  9. Diuresis [ Time Frame: Baseline ]
    Volume of urinary secretion in the last 12 hours

  10. KDIGO classification [ Time Frame: Baseline ]
    The KDIGO classification defines 3 stages of increasing severity for acute kidney injuries.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. Total Ca (calcium) concentration -dialysate [ Time Frame: 30 minutes after the start of dialysis ]
    Ca (calcium) concentration in the dialysate

  20. 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

  21. 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

  22. Ionized calcium (Ca2+) concentration -dialysate [ Time Frame: 30 minutes after the start of dialysis ]
    Ca (calcium) concentration in the dialysate

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. Albumin concentration -pre-filter [ Time Frame: 30 minutes after the start of dialysis ]
    Albumin concentration in a blood sample taken before the dialysis filter

  30. Albumin concentration -post-filter [ Time Frame: 30 minutes after the start of dialysis ]
    Albumin concentration in a blood sample taken after the dialysis filter

  31. pH - pre-filter [ Time Frame: 30 minutes after the start of dialysis ]
    pH of a blood sample taken before the dialysis filter

  32. pH - post-filter [ Time Frame: 30 minutes after the start of dialysis ]
    pH of a blood sample taken after the dialysis filter

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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


Eligibility Criteria
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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
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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Contact: Sébastien Redant, MD 3224773100 Sebastien.REDANT@chu-brugmann.be

Locations
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Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: David De Bels, MD    3224779127    David.DEBELS@chu-brugmann.be   
Sponsors and Collaborators
Dr David DE BELS
Investigators
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Principal Investigator: Sébastien Redant, MD CHU Brugmann
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
 Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action