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

Completed

• Conditions: End Stage Renal Disease
• Interventions: Other: blood sampling

• Registration Number: NCT04530175
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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

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 Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Study Start: 2021-02-02
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with hemodialysis	blood sampling	patient treated with intermittent hemodialysis for chronic renal failure

Primary Outcome Measures

Name	Time	Method
Ionized calcium level	day 0	measured at dialyzer inlet, in mmol/L
Total citratemia	day 0	measured at dialyzer inlet, in mmol/L
Total calcium level	day 0	measured at dialyzer inlet, in mmol/L

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France