DialysisNCT04024007
Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits
An observational study of Dialysis, run by Dr David DE BELS at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis
- What is being tested?
- Citrate dosage
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Intensive care dialysis patients (Continuous Venous Hemofiltration with citrate).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
David De Bels, MD, 3224779127, David.DEBELS@chu-brugmann.be
About this study
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.
- Conditions
- Dialysis
- Being tested
- Citrate dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrate dosageDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Citrate dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Citrate concentration - pre-filter
Citrate concentration in a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
Citrate concentration - post-filter
Citrate concentration in a blood sample taken after the dialysis filter
Measured: 30 minutes after the start of dialysis
Citrate concentration - dialysate
Citrate concentration in a blood sample taken in the dialysate
Measured: 30 minutes after the start of dialysis
Secondary outcomes (38)
Age
Age
Measured: Baseline
Weight
Weight
Measured: Baseline
Height
Height
Measured: Baseline
Sex
Sex
Measured: 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.
Measured: 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.
Measured: Baseline
Glomerular filtration rate (GFR)
Glomerular filtration rate
Measured: Baseline
Creatinin level
Creatinin level
Measured: Baseline
Diuresis
Volume of urinary secretion in the last 12 hours
Measured: Baseline
KDIGO classification
The KDIGO classification defines 3 stages of increasing severity for acute kidney injuries.
Measured: Baseline
Na (sodium) concentration -pre-filter
Na (sodium) concentration in a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
Na (sodium) concentration -post-filter
Na (sodium) concentration in a blood sample taken after the dialysis filter
Measured: 30 minutes after the start of dialysis
Cl (chlorine) concentration - pre-filter
Cl (chlorine) concentration in a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
Cl (chlorine) concentration -post-filter
Cl (chlorine) concentration in a blood sample taken after the dialysis filter
Measured: 30 minutes after the start of dialysis
K (potassium) concentration - pre-filter
K (potassium) concentration in a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
K (potassium) concentration - post-filter
K (potassium) concentration in a blood sample taken after the dialysis filter
Measured: 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
Measured: 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
Measured: 30 minutes after the start of dialysis
Total Ca (calcium) concentration -dialysate
Ca (calcium) concentration in the dialysate
Measured: 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
Measured: 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
Measured: 30 minutes after the start of dialysis
Ionized calcium (Ca2+) concentration -dialysate
Ca (calcium) concentration in the dialysate
Measured: 30 minutes after the start of dialysis
Mg (magnesium) concentration - pre-filter
Mg (magnesium) concentration in a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
Mg (magnesium) concentration - post-filter
Mg (magnesium) concentration in a blood sample taken after the dialysis filter
Measured: 30 minutes after the start of dialysis
PO4 (phosphate) concentration - pre-filter
PO4 (phosphate) concentration in a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
PO4 (phosphate) concentration - post-filter
PO4 (phosphate) concentration in a blood sample taken after the dialysis filter
Measured: 30 minutes after the start of dialysis
Lactate concentration - pre-filter
Lactate blood concentration in a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
Lactate concentration - post-filter
Lactate blood concentration in a blood sample taken after the dialysis filter
Measured: 30 minutes after the start of dialysis
Albumin concentration -pre-filter
Albumin concentration in a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
Albumin concentration -post-filter
Albumin concentration in a blood sample taken after the dialysis filter
Measured: 30 minutes after the start of dialysis
pH - pre-filter
pH of a blood sample taken before the dialysis filter
Measured: 30 minutes after the start of dialysis
pH - post-filter
pH of a blood sample taken after the dialysis filter
Measured: 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
Measured: 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
Measured: 30 minutes after the start of dialysis
Total C-reactive protein (CRP) -dialysate
Total CRP concentration in a blood sample taken in the dialysate
Measured: 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
Measured: 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
Measured: 30 minutes after the start of dialysis
Monomeric C-reactive protein (CRP) -dialysate
Monomeric CRP concentration in a blood sample taken in the dialysate
Measured: 30 minutes after the start of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr David DE BELS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr David DE BELS, Brugmann University Hospital
- Investigators
- Sébastien Redant, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024007
- Sponsor's protocol ID
- CHUB-citrate
- Status last verified
- Mar 2022
- First submitted
- 16 Jul 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits
- ClinicalTrials.gov ID
- NCT04024007
- Acronym / sponsor ID
- CHUB-citrate
- Conditions
- Dialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr David DE BELSUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis patients | – | Diagnostic Test: Citrate dosageIntensive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Intensive care dialysis patients (Continuous Venous Hemofiltration with citrate).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citrate dosagePatients 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. | Diagnostic test | Dialysis patients |
Primary outcome
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
38 secondary outcomes
Age
Time frame: Baseline
Weight
Time frame: Baseline
Height
Time frame: Baseline
Sex
Time frame: Baseline
Apache II score
Time frame: Baseline
SOFA (Sequential Organ Failure Assessment) score
Time frame: Baseline
Glomerular filtration rate (GFR)
Time frame: Baseline
Creatinin level
Time frame: Baseline
Diuresis
Time frame: Baseline
KDIGO classification
Time frame: Baseline
Na (sodium) concentration -pre-filter
Time frame: 30 minutes after the start of dialysis
Na (sodium) concentration -post-filter
Time frame: 30 minutes after the start of dialysis
Cl (chlorine) concentration - pre-filter
Time frame: 30 minutes after the start of dialysis
Cl (chlorine) concentration -post-filter
Time frame: 30 minutes after the start of dialysis
K (potassium) concentration - pre-filter
Time frame: 30 minutes after the start of dialysis
K (potassium) concentration - post-filter
Time frame: 30 minutes after the start of dialysis
Total Ca (calcium) concentration -pre-filter
Time frame: 30 minutes after the start of dialysis
Total Ca (calcium) concentration -post-filter
Time frame: 30 minutes after the start of dialysis
Total Ca (calcium) concentration -dialysate
Time frame: 30 minutes after the start of dialysis
Ionized calcium (Ca2+) concentration -pre-filter
Time frame: 30 minutes after the start of dialysis
Ionized calcium (Ca2+) concentration -post-filter
Time frame: 30 minutes after the start of dialysis
Ionized calcium (Ca2+) concentration -dialysate
Time frame: 30 minutes after the start of dialysis
Mg (magnesium) concentration - pre-filter
Time frame: 30 minutes after the start of dialysis
Mg (magnesium) concentration - post-filter
Time frame: 30 minutes after the start of dialysis
PO4 (phosphate) concentration - pre-filter
Time frame: 30 minutes after the start of dialysis
PO4 (phosphate) concentration - post-filter
Time frame: 30 minutes after the start of dialysis
Lactate concentration - pre-filter
Time frame: 30 minutes after the start of dialysis
Lactate concentration - post-filter
Time frame: 30 minutes after the start of dialysis
Albumin concentration -pre-filter
Time frame: 30 minutes after the start of dialysis
Albumin concentration -post-filter
Time frame: 30 minutes after the start of dialysis
pH - pre-filter
Time frame: 30 minutes after the start of dialysis
pH - post-filter
Time frame: 30 minutes after the start of dialysis
Total C-reactive protein (CRP) -pre-filter
Time frame: 30 minutes after the start of dialysis
Total C-reactive protein (CRP) -post-filter
Time frame: 30 minutes after the start of dialysis
Total C-reactive protein (CRP) -dialysate
Time frame: 30 minutes after the start of dialysis
Monomeric C-reactive protein (CRP) -pre-filter
Time frame: 30 minutes after the start of dialysis
Monomeric C-reactive protein (CRP) -post-filter
Time frame: 30 minutes after the start of dialysis
Monomeric C-reactive protein (CRP) -dialysate
Time frame: 30 minutes after the start of dialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Redant, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis, run by Dr David DE BELS at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Redant, MD (3224773100, Sebastien.REDANT@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Citrate concentration - pre-filter (time frame: 30 minutes after the start of dialysis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.