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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Completed

Conditions

Diagnosis
Diagnostic Imaging
Kidney Disease

Treatments

Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

Study type

Observational

Funder types

Other

Identifiers

NCT04044404
2019-52-K33 (Other Identifier)
RJ2018049

Details and patient eligibility

About

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.

Enrollment

208 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

208 participants in 3 patient groups

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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