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

Study Overview
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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.

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

Conditions
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Diagnostic Imaging, Diagnosis, Kidney Disease

Intervention / Treatment
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* Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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. for kidney transplantation 18-70 years old; gender is not limited; It can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles. The informed consent has been signed; Kidney transplant recipients in our hospital from May 2019 to November 2019 Exclusion criteria for A on C group Can't cooperate, can't lie down for at least 10 minutes, unconsciousness, severe hypoxia, restlessness need to rescue patients. Patients with pregnancy or cancer; There are other serious diseases that the researchers do not think it is suitable to participate in this experiment. 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 Can't cooperate, can't lie down for at least 10 minutes, unconsciousness, severe hypoxia, restlessness need to rescue patients. Patients with pregnancy or cancer; There are other serious diseases that the researchers do not think it is suitable to participate in this experiment. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A on C group<br>Acute on Chronic Kidney Disease patients | Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)<br>* Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy<br>|
| functional delayed graft function group<br>patients with functional delayed graft function(fDGF) after kidney transplantation | Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)<br>* Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy<br>|
| Normal<br>without functional kidney injury | Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)<br>* Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of patients with initiation of continuous renal replacement therapy | for non-transplantation patient | 1st month-12 month | 
| Rate of death | for all patients | 1st month-12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of patients with cerebrovascular events | (cerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, transient ischemic attack or death from cerebrovascular diseases); | 1st month-12 month | 
| Number of patients with new serious infections requiring hospitalization | for all kidney injury | 1st month-12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound Elastography, Ultrasound Integrated Precision Diagnosis Technology, Acute on Chronic Kidney Disease, Kidney transplantation, kidney fibrosis