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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dialysis

Intervention / Treatment
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* Diagnostic Test: Citrate dosage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Intensive care dialysis patients (Continuous Venous Hemofiltration with citrate). Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dialysis patients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Citrate concentration - pre-filter | Citrate concentration in a blood sample taken before the dialysis filter | 30 minutes after the start of dialysis | 
| Citrate concentration - post-filter | Citrate concentration in a blood sample taken after the dialysis filter | 30 minutes after the start of dialysis | 
| Citrate concentration - dialysate | Citrate concentration in a blood sample taken in the dialysate | 30 minutes after the start of dialysis | 

Secondary Outcome Measures

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