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EMTDialyse: Trace Elements Concentration in Dialysis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05031013
Collaborator
laboratoire ILM - Université Lyon 1 CNRS, UMR 5306 UCBL (Other), MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne (Other)
40
Enrollment
1
Location
5
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In hemodialysis population the study team finds high concentrations of toxic trace elements (2 times higher than the general population for cadmium 4 to 13 times for lead). Several recent studies suggest a role of chronic exposure to cadmium in the loss of residual renal function, osteoporosis, graft failure, arteriosclerosis, as well as in excess cardiovascular mortality.

Moreover, in hemodialysis population, a deficit of certain essential trace elements (manganese, selenium, zinc) is observed. For example, in the population undergoing chronic hemodialysis, a zinc deficiency is found in 40 to 78% of cases. Zinc is a cofactor of more than 70 enzymes.

In this observational cohort, the study team seeks to understand the impact of HD and HDF on the serum concentrations of heavy metals and also oligometals, by studying their concentrations in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Primary objective: Evaluate the trace element concentration (heavy metals Cd and Pb and oligometals: Fe, Zn, Cu, Mn and also Se) in the dialysate before and during dialysis session. By studying the variation in concentration between the initial concentration of trace element in the dialysis fluid and the final concentration after membrane in the dialysate (waste pipe).

    Method : Prospective study, in dialysis population, inclusion period will be from September 1, 2021 to January 31, 2022, in Ambroise Paré hospital, Paris, France. Duration of follow-up will be 1 day.

    Dialysate samples will be taken in the venous injection site before connecting the patient, at 0 and 10 minutes after disinfection.

    After connecting the patients, post-membrane dialysis sample (waste pipe) will be taken at 30, 60, 120 and 180minutes. Trace element dosage will be done by ICP-MS.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Trace Elements Concentration in Dialysis
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Jan 31, 2022
    Anticipated Study Completion Date :
    Feb 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Dialysis patients

    Dialysis patients

    Outcome Measures

    Primary Outcome Measures

    1. Trace elements concentration [5 months]

      Trace elements concentration in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age over 18;

    • End-stage chronic renal failure in chronic dialysis;

    • Duration of dialysis session ≥3h;

    • Vascular approach: arteriovenous fistula;

    • Affiliation to a social security scheme or entitled.

    Exclusion Criteria:

    • Opposition to participate to the study;

    • Daily dialysis;

    • Duration of dialysis session < 3h and > 8h;

    • Vascular approach: venous catheter; Weekly dialysis session ≤3; Patient under french AME health system.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nephrology Department and Dialysis Unit Boulogne-Billancourt France 92100

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris
    • laboratoire ILM - Université Lyon 1 CNRS, UMR 5306 UCBL
    • MEXBrain 13 avenue Albert Einstein 69100 Villeurbanne

    Investigators

    • Principal Investigator: Aymeric Couturier, MD, Service néphrologie et dialyse, hôpital Ambroise Paré

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05031013
    Other Study ID Numbers:
    • 021ACR-EMTDialyse
    First Posted:
    Sep 1, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    dialysis
    trace elements concentration
    cadmium
    lead

    Study Results

    No Results Posted as of Sep 16, 2021