End Stage Renal DiseaseMARCNCT04530175
Modeling of Regional Citrate Anticoagulation With a Dialysate Containing Calcium in Intermittent Hemodialysis (MARC)
An observational study of End Stage Renal Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The primary purpose of this study is to validate a mathematical modeling of treatment by intermittent hemodialysis using regional citrate anticoagulation with a dialysate containing calcium Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- blood sampling
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2021to 7 Jul 2021
- 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: patients treated with intermittent hemodialysis for chronic renal failure, at university hospital of Clermont-Ferrand
Who may be able to join
- Major patient;
- Man or woman ;
- Treated with intermittent hemodialysis for chronic renal failure;
- In whom intermittent hemodialysis with citrate solution for regional anticoagulation is indicated;
- Affiliated with a social security scheme;
- Having given a signed agreement after detailed explanation of the protocol on the basis of the information sheet and likely to comply with it
Who cannot join
- Severe hepato-cellular insufficiency (PT <50%, INR> 1.5 without anticoagulant);
- Hemoglobin level <7 g / dL
- Presenting a psychiatric pathology or cognitive impairment rendering him unable to give informed consent;
- Persons under guardianship, curatorship, deprived of liberty or safeguard of justice
- Pregnant or breastfeeding women
- Patient's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modeling of Regional Citrate Anticoagulation With a Dialysate Containing Calcium in Intermittent Hemodialysis
The primary purpose of this study is to validate a mathematical modeling of treatment by intermittent hemodialysis using regional citrate anticoagulation with a dialysate containing calcium
Read the detailed description
The only visit to the study will be carried out during a usual dialysis session in the intensive care unit of Clermont-Ferrand University Hospital. In addition to the usual care, 2 blood samples will be taken from the blood circuit 1 hour after the start of the hemodialysis session by the nurse in charge of the patient.
- Conditions
- End Stage Renal Disease
- Being tested
- blood sampling
- Keywords
- hemodialysis, modeling, Citrate anticoagulation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
2 blood samples will be taken from the blood circuit 1 hour after the start of the hemodialysis session by the nurse in charge of the patient.
| Study group | Role | What they receive |
|---|---|---|
| patients with hemodialysis | patient treated with intermittent hemodialysis for chronic renal failure Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ionized calcium level
measured at dialyzer inlet, in mmol/L
Measured: day 0
Total calcium level
measured at dialyzer inlet, in mmol/L
Measured: day 0
Total citratemia
measured at dialyzer inlet, in mmol/L
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start2 Feb 2021
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Aniort, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530175
- Sponsor's protocol ID
- RBHP 2020 ANIORT
- Other IDs
- 2020-A01359-30
- Acronym
- MARC
- Status last verified
- Feb 2022
- First submitted
- 25 Aug 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling of Regional Citrate Anticoagulation With a Dialysate Containing Calcium in Intermittent Hemodialysis
- ClinicalTrials.gov ID
- NCT04530175
- Acronym / sponsor ID
- MARC / RBHP 2020 ANIORT
- Conditions
- End Stage Renal Disease
- Keywords
- hemodialysis, modeling, Citrate anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 28 Aug 2020 (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.
The primary purpose of this study is to validate a mathematical modeling of treatment by intermittent hemodialysis using regional citrate anticoagulation with a dialysate containing calcium
Detailed description
The only visit to the study will be carried out during a usual dialysis session in the intensive care unit of Clermont-Ferrand University Hospital. In addition to the usual care, 2 blood samples will be taken from the blood circuit 1 hour after the start of the hemodialysis session by the nurse in charge of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with hemodialysis | – | Other: blood samplingpatient treated with intermittent hemodialysis for chronic renal failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with intermittent hemodialysis for chronic renal failure, at university hospital of Clermont-Ferrand
Key inclusion criteria (6 listed)
- Major patient;
- Man or woman ;
- Treated with intermittent hemodialysis for chronic renal failure;
- In whom intermittent hemodialysis with citrate solution for regional anticoagulation is indicated;
- Affiliated with a social security scheme;
Key exclusion criteria (6 listed)
- Severe hepato-cellular insufficiency (PT <50%, INR> 1.5 without anticoagulant);
- Hemoglobin level <7 g / dL
- Presenting a psychiatric pathology or cognitive impairment rendering him unable to give informed consent;
- Persons under guardianship, curatorship, deprived of liberty or safeguard of justice
- Pregnant or breastfeeding women
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 |
|---|---|---|
| blood sampling2 blood samples will be taken from the blood circuit 1 hour after the start of the hemodialysis session by the nurse in charge of the patient. | Other | patients with hemodialysis |
Primary outcome
Ionized calcium level
Time frame: day 0
measured at dialyzer inlet, in mmol/L
Total calcium level
Time frame: day 0
measured at dialyzer inlet, in mmol/L
Total citratemia
Time frame: day 0
measured at dialyzer inlet, in mmol/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
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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.
Julien Aniort principal investigator
University Hospital, Clermont-Ferrand
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 End Stage Renal Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 9 Feb 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ionized calcium level (time frame: day 0). 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 9 Feb 2022.