Modeling of Regional Citrate Anticoagulation With a Dialysate Containing Calcium in Intermittent Hemodialysis (MARC) (MARC)

February 8, 2022 updated by: University Hospital, Clermont-Ferrand

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand

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

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

patients treated with intermittent hemodialysis for chronic renal failure, at university hospital of Clermont-Ferrand

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with hemodialysis
patient treated with intermittent hemodialysis for chronic renal failure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ionized calcium level
Time Frame: day 0
measured at dialyzer inlet, in mmol/L
day 0
Total calcium level
Time Frame: day 0
measured at dialyzer inlet, in mmol/L
day 0
Total citratemia
Time Frame: day 0
measured at dialyzer inlet, in mmol/L
day 0

Collaborators and Investigators

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

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)

February 2, 2021

Primary Completion (Actual)

July 7, 2021

Study Completion (Actual)

July 7, 2021

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • RBHP 2020 ANIORT
  • 2020-A01359-30 (Other Identifier: ANSM)

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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