Application of Ultrasound Integrated Precision Diagnosis Technology in Prevention of Kidney Disease and Its Progress

Completed

• Conditions: Diagnostic Imaging; Kidney Disease; Diagnosis
• Interventions: Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

• Registration Number: NCT04044404
• Lead Sponsor: RenJi Hospital

Brief Summary

In this study, a prospective, randomized and controlled clinical study would be carried out to establish Ultrasound Integrated Precision Diagnosis Technology with elastography as the core technology to evaluate renal injury and repair comprehensively and accurately, and to improve the clinical diagnosis chance of renal injury (or renal fibrosis).

Combined with the dynamic changes of biomarkers (inflammatory factors, cytokines secreted by immune cells, etc.) after kidney injury, the research on the prognosis of kidney disease with ultrasound elastography technology as the core would be explored, which aims to provide a scientific basis for the application of Ultrasound Integrated Precision Diagnosis Technology.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-29
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Primary Completion: 2021-05-29
• Study Completion: 2021-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal	Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)	without functional kidney injury
functional delayed graft function group	Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)	patients with functional delayed graft function(fDGF) after kidney transplantation
A on C group	Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)	Acute on Chronic Kidney Disease patients

Primary Outcome Measures

Name	Time	Method
Number of patients with creatinine increasing by more than 50%	1st month-12 month	Number of patients with creatinine increasing by more than 50% of baseline.
Rate of death	1st month-12 month	for all patients
Number of patients with initiation of continuous renal replacement therapy	1st month-12 month	for non-transplantation patient

Secondary Outcome Measures

Name	Time	Method
Number of patients with cardiovascular events	1st month-12 month	(acute myocardial infarction, unstable angina pectoris, heart failure requiring hospitalization or death from cardiovascular diseases);
Number of patients with new serious infections requiring hospitalization	1st month-12 month	for all kidney injury
Number of patients with cerebrovascular events	1st month-12 month	(cerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, transient ischemic attack or death from cerebrovascular diseases);

Trial Locations

Locations (2)

Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, China