Kidney Transplant Volumetry

Completed

• Conditions: Kidney Transplant; Complications

• Registration Number: NCT03855085
• Lead Sponsor: University Hospital, Tours

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.

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 Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-26
• Study Start: 2019-07-25
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Intraclass coefficient of correlation of the volume formula parameters.	6 months	The reproducibility of each formula parameter will also be assessed.

Trial Locations

Locations (1)

Gradinaru; 🇫🇷 Tours, France