Modeling of Regional Citrate Anticoagulation With a Dialy... | NCT04530175

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

NCT04530175

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Feb 9, 2022Actual

Enrollment

30Actual

Phase

Not provided

Conditions

End Stage Renal Disease

Interventions

blood sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A01359-30	Other Identifier	ANSM

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2021Actual

Primary Completion Date

Jul 7, 2021Actual

Completion Date

Jul 7, 2021Actual

First Submitted Date

Aug 25, 2020

First Submission Date that Met QC Criteria

Aug 25, 2020

First Posted Date

Aug 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2022

Last Update Posted Date

Feb 9, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with hemodialysis		patient treated with intermittent hemodialysis for chronic renal failure	Other: blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julien Aniort	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand		Clermont-Ferrand		63000	France

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided