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

March 3, 2022 updated by: Dr David DE BELS

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Citrate concentration - pre-filter
Time Frame: 30 minutes after the start of dialysis
Citrate concentration in a blood sample taken before the dialysis filter
30 minutes after the start of dialysis
Citrate concentration - post-filter
Time Frame: 30 minutes after the start of dialysis
Citrate concentration in a blood sample taken after the dialysis filter
30 minutes after the start of dialysis
Citrate concentration - dialysate
Time Frame: 30 minutes after the start of dialysis
Citrate concentration in a blood sample taken in the dialysate
30 minutes after the start of dialysis

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Baseline
Age
Baseline
Sex
Time Frame: Baseline
Sex
Baseline
Weight
Time Frame: Baseline
Weight
Baseline
Height
Time Frame: Baseline
Height
Baseline
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.
Baseline
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.
Baseline
Glomerular filtration rate (GFR)
Time Frame: Baseline
Glomerular filtration rate
Baseline
Creatinin level
Time Frame: Baseline
Creatinin level
Baseline
Diuresis
Time Frame: Baseline
Volume of urinary secretion in the last 12 hours
Baseline
KDIGO classification
Time Frame: Baseline
The KDIGO classification defines 3 stages of increasing severity for acute kidney injuries.
Baseline
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
Total Ca (calcium) concentration -dialysate
Time Frame: 30 minutes after the start of dialysis
Ca (calcium) concentration in the dialysate
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
Ionized calcium (Ca2+) concentration -dialysate
Time Frame: 30 minutes after the start of dialysis
Ca (calcium) concentration in the dialysate
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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 minutes after the start of dialysis
Albumin concentration -post-filter
Time Frame: 30 minutes after the start of dialysis
Albumin concentration in a blood sample taken after the dialysis filter
30 minutes after the start of dialysis
pH - pre-filter
Time Frame: 30 minutes after the start of dialysis
pH of a blood sample taken before the dialysis filter
30 minutes after the start of dialysis
pH - post-filter
Time Frame: 30 minutes after the start of dialysis
pH of a blood sample taken after the dialysis filter
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis
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
30 minutes after the start of dialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr David DE BELS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sébastien Redant, MD, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUB-citrate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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