Kidney Transplant Volumetry

Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant; Complications

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Gradinaru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraclass coefficient of correlation of the ultrasound volume measurement	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraclass coefficient of correlation of the volume formula parameters.	The reproducibility of each formula parameter will also be assessed.	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): December 17, 2019
• Study Completion (Actual): December 17, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound; Kidney transplant; volumetry
• Other Study ID Numbers: RIPH3-RNI19-Volumetrie GreffeR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No