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Completed

NCT Number: NCT03855085

Kidney Transplant Volumetry

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.

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Key information

Conditions

Kidney Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gradinaru

Tours, 37044, France

About this study

The 3 series of measurements

  • Longitudinal section: maximum longitudinal length, width at the hilum, maximum width, width at the upper third, longitudinal cross-sectional area
  • Transverse section at the hilum : thickness, width, hilar cross-sectional area
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intraclass coefficient of correlation of the ultrasound volume measurement

    Time frame: 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 outcomes

  1. Intraclass coefficient of correlation of the volume formula parameters.

    Time frame: 6 months

    The reproducibility of each formula parameter will also be assessed.

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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