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

NCT ID: NCT04044404

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-29

Study Completion Date

2021-06-30

Brief Summary

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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

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Conditions

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Diagnostic Imaging Diagnosis Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A on C group

Acute on Chronic Kidney Disease patients

Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

Intervention Type DIAGNOSTIC_TEST

Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy

functional delayed graft function group

patients with functional delayed graft function(fDGF) after kidney transplantation

Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

Intervention Type DIAGNOSTIC_TEST

Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy

Normal

without functional kidney injury

Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

Intervention Type DIAGNOSTIC_TEST

Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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, ① Obvious bleeding tendency; ②Severe hypertension (systolic pressure greater than 180 mm Hg or diastolic pressure greater than 115 mm Hg); ③Psychiatric patients or non-cooperating operators and isolated kidney (small kidney) Or relative contraindications of renal puncture: ① Active pyelonephritis, renal tuberculosis, hydronephrosis or pyonephrosis, ②renal abscess or perirenal abscess. ③Renal tumors or renal aneurysms. ④Polycystic kidney or renal cyst. ⑤Kidney position is too high (deep inhalation of the lower pole of the kidney is not below the twelve ribs) or migratory kidney. ⑥Obesity, severe ascites.

b)for kidney transplantation

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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, ① Obvious bleeding tendency; ②Severe hypertension (systolic pressure greater than 180 mm Hg or diastolic pressure greater than 115 mm Hg); ③Psychiatric patients or non-cooperating operators and isolated kidney (small kidney) Or relative contraindications of renal puncture: ① Active pyelonephritis, renal tuberculosis, hydronephrosis or pyonephrosis, ②renal abscess or perirenal abscess. ③Renal tumors or renal aneurysms. ④Polycystic kidney or renal cyst. ⑤Kidney position is too high (deep inhalation of the lower pole of the kidney is not below the twelve ribs) or migratory kidney. ⑥Obesity, severe ascites.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

China-Japan Friendship Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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2019-52-K33

Identifier Type: OTHER

Identifier Source: secondary_id

RJ2018049

Identifier Type: -

Identifier Source: org_study_id