Kidney Transplant Volumetry

Kidney Transplant; Complications Clinical Trial

Official title:

Assessment of the Reproducibility of Kidney Transplant Sonographic Volume Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855085
• Other study ID #: RIPH3-RNI19-Volumetrie GreffeR
• Status: Completed
• Start date: July 25, 2019
• Est. completion date: December 17, 2019

Study information

• Verified date: January 2020
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 17, 2019
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Locations

Country	Name	City	State
France	Gradinaru	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraclass coefficient of correlation of the volume formula parameters.	The reproducibility of each formula parameter will also be assessed.	6 months