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Completed

NCT Number: NCT04530175

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

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

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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.

Primary outcomes

  1. Ionized calcium level

    Time frame: day 0

    measured at dialyzer inlet, in mmol/L

  2. Total calcium level

    Time frame: day 0

    measured at dialyzer inlet, in mmol/L

  3. Total citratemia

    Time frame: day 0

    measured at dialyzer inlet, in mmol/L

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: MARC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2020
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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