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

Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044404
• Other study ID #: RJ2018049
• Secondary ID: 2019-52-K33
• Status: Completed
• Start date: April 29, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: June 30, 2021
• Est. primary completion date: May 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria

1. for A on C group 1.18-70 years old; gender is not limited; 2. Patients who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles.

3.The informed consent has been signed; 4.Abnormal renal pathology or glomerular filtration rate(GFR) (15 <GFR<90 ml/min.1.73 m2) or proteinuria > 1 g/24 h due to any cause.

2. for kidney transplantation

1. 18-70 years old; gender is not limited;

2. It can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles.

3. The informed consent has been signed;

4. Kidney transplant recipients in our hospital from May 2019 to November 2019

Exclusion criteria

1. for A on C group

1. Can't cooperate, can't lie down for at least 10 minutes, unconsciousness, severe hypoxia, restlessness need to rescue patients.

2. Patients with pregnancy or cancer;

3. There are other serious diseases that the researchers do not think it is suitable to participate in this experiment.

4. Absolute contraindications of renal puncture, ? Obvious bleeding tendency; ?Severe hypertension (systolic pressure greater than 180 mm Hg or diastolic pressure greater than 115 mm Hg); ?Psychiatric patients or non-cooperating operators and isolated kidney (small kidney) Or relative contraindications of renal puncture: ? Active pyelonephritis, renal tuberculosis, hydronephrosis or pyonephrosis, ?renal abscess or perirenal abscess. ?Renal tumors or renal aneurysms. ?Polycystic kidney or renal cyst. ?Kidney position is too high (deep inhalation of the lower pole of the kidney is not below the twelve ribs) or migratory kidney. ?Obesity, severe ascites.

b)for kidney transplantation

1. Can't cooperate, can't lie down for at least 10 minutes, unconsciousness, severe hypoxia, restlessness need to rescue patients.

2. Patients with pregnancy or cancer;

3. There are other serious diseases that the researchers do not think it is suitable to participate in this experiment.

4. Absolute contraindications of renal puncture, ? Obvious bleeding tendency; ?Severe hypertension (systolic pressure greater than 180 mm Hg or diastolic pressure greater than 115 mm Hg); ?Psychiatric patients or non-cooperating operators and isolated kidney (small kidney) Or relative contraindications of renal puncture: ? Active pyelonephritis, renal tuberculosis, hydronephrosis or pyonephrosis, ?renal abscess or perirenal abscess. ?Renal tumors or renal aneurysms. ?Polycystic kidney or renal cyst. ?Kidney position is too high (deep inhalation of the lower pole of the kidney is not below the twelve ribs) or migratory kidney. ?Obesity, severe ascites.

Related Conditions & MeSH terms

• Diagnosis
• Diagnostic Imaging
• Disease
• Kidney Disease
• Kidney Diseases

Intervention

Diagnostic Test:
• Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)
Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing
China	Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
RenJi Hospital	China-Japan Friendship Hospital, Duke University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with recovery of creatinine within 7 days less than 70%.	for renal transplantation patient	1st month-12 month
Other	Number of patients with allograft loss	for renal transplantation patient	1st month-12 month
Primary	Number of patients with creatinine increasing by more than 50%	Number of patients with creatinine increasing by more than 50% of baseline.	1st month-12 month
Primary	Number of patients with initiation of continuous renal replacement therapy	for non-transplantation patient	1st month-12 month
Primary	Rate of death	for all patients	1st month-12 month
Secondary	Number of patients with cardiovascular events	(acute myocardial infarction, unstable angina pectoris, heart failure requiring hospitalization or death from cardiovascular diseases);	1st month-12 month
Secondary	Number of patients with cerebrovascular events	(cerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, transient ischemic attack or death from cerebrovascular diseases);	1st month-12 month
Secondary	Number of patients with new serious infections requiring hospitalization	for all kidney injury	1st month-12 month