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Kidney Transplant Volumetry

Sponsor
University Hospital, Tours (Other)
Overall Status
Completed
CT.gov ID
NCT03855085
Collaborator
(none)
100
Enrollment
1
Location
4.8
Actual Duration (Months)
21
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study assesses the reproducibility of 3 different formulas in calculating the volume of a transplanted kidney by ultrasound in-vivo measurements.

3 series of measurements will be performed by 2 different operators during the usual ultrasound follow-up of the renal transplant.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The 3 series of measurements

    1. Longitudinal section: maximum longitudinal length, width at the hilum, maximum width, width at the upper third, longitudinal cross-sectional area

    2. Transverse section at the hilum : thickness, width, hilar cross-sectional area

    3. Largest transverse section : thickness, width, maximum transverse cross-sectional area

    Clinical and biological patient data collection:

    age, gender, date of transplantation, serum creatinine and glomerular filtration rate (GFR), kidney transplant placement (right or left iliac fossa), acute illness or usual follow-up

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement
    Actual Study Start Date :
    Jul 25, 2019
    Actual Primary Completion Date :
    Dec 17, 2019
    Actual Study Completion Date :
    Dec 17, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Intraclass coefficient of correlation of the ultrasound volume measurement [6 months]

      The inter-observer and intra-observer variability of the ultrasound volume measurement of the kidney graft will be assessed using the intraclass coefficient of correlation (ICC)

    Secondary Outcome Measures

    1. Intraclass coefficient of correlation of the volume formula parameters. [6 months]

      The reproducibility of each formula parameter will also be assessed.

    Eligibility Criteria

    Criteria

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

    • Kidney transplant recepients with ultrasound follow-up at the University Hospital of Tours

    • Age more than 18 years old

    Exclusion Criteria:

    • Renal deformity of extrinsic origin

    • Early post-transplant period (first 3 days post-transplant)

    • Transplanted organ out of the field of view

    • Dual kidney transplant

    • Opposition to the data collection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gradinaru Tours France 37044

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT03855085
    Other Study ID Numbers:
    • RIPH3-RNI19-Volumetrie GreffeR
    First Posted:
    Feb 26, 2019
    Last Update Posted:
    Jan 7, 2020
    Last Verified:
    Jan 1, 2020
    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 University Hospital, Tours
    Kidney transplant
    volumetry
    ultrasound

    Study Results

    No Results Posted as of Jan 7, 2020