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

End Stage Renal Disease Clinical Trial

— MARC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530175
• Other study ID #: RBHP 2020 ANIORT
• Secondary ID: 2020-A01359-30
• Status: Completed
• Start date: February 2, 2021
• Est. completion date: July 7, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• blood sampling
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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ionized calcium level	measured at dialyzer inlet, in mmol/L	day 0
Primary	Total calcium level	measured at dialyzer inlet, in mmol/L	day 0
Primary	Total citratemia	measured at dialyzer inlet, in mmol/L	day 0