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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 : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Dr David DE BELS, Brugmann University Hospital

Tracking Information
First Submitted Date July 16, 2019
First Posted Date July 18, 2019
Last Update Posted Date January 30, 2020
Actual Study Start Date September 1, 2019
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Citrate dosage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 16, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2023
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sébastien Redant, MD 3224773100 Sebastien.REDANT@chu-brugmann.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024007
Other Study ID Numbers CHUB-citrate
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr David DE BELS, Brugmann University Hospital
Study Sponsor Dr David DE BELS
Collaborators Not Provided
Investigators
Principal Investigator: Sébastien Redant, MD CHU Brugmann
PRS Account Brugmann University Hospital
Verification Date January 2020