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

NCT04530175 | Completed

• 2 other identifiers: RBHP 2020 ANIORT2020-A01359-30
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Renal Disease

Keywords

hemodialysis; modeling; Citrate anticoagulation

Outcome Measures

Primary Outcomes (3)

• Ionized calcium level

  measured at dialyzer inlet, in mmol/L

  day 0

• Total calcium level

  measured at dialyzer inlet, in mmol/L

  day 0

• Total citratemia

  measured at dialyzer inlet, in mmol/L

  day 0

Study Arms (1)

patients with hemodialysis

patient treated with intermittent hemodialysis for chronic renal failure

Other: blood sampling

Interventions

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.

patients with hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Julien Aniort

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: February 2, 2021
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

FR (1)