Evaluation of Advanced US Tools in Assessing Allograft Complications

Chronic Kidney Diseases Clinical Trial

Official title:

The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423458
• Other study ID #: 848 -20HH6053
• Status: Completed
• Start date: January 4, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.

Description:

This study will focus on monitoring renal after transplantation using all US advanced technology.

Aim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard.

Aim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.

Aim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups.

Duration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained.

Study data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA

• Patients = 18 years.

• Tx patients.

• Gender.

EXCLUSION CRITERIA

• Prisoners.

• Patients < 18 years.

• Pregnant women

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Complications
• Fibrosis
• Kidney Diseases
• Renal Artery Obstruction
• Renal Artery Stenosis
• Renal Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• 3D imaging
The study will focus on the accuracy of ultrasound technology in assessing renal transplants. The entire assessment should not take more than 25 minutes.

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak systolic velocity (cm/s).	Pean of the blood flow velocities in the artery/ vein peak systolic velocity =200 cm/s velocity difference between pre- and post-stenotic segments of 2:1	12 weeks
Primary	Peak systolic velocity ratio (PSVR).	High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)	12 weeks
Primary	Resistive Index (RI).	An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.	12 weeks
Secondary	Volumetric stenosis.	Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.	12 weeks
Secondary	3D GSM.	Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.	12 weeks