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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-52-K33 | Other Identifier | China-Japan Friendship Hospital |
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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| Duke University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A on C group | Acute on Chronic Kidney Disease patients |
| |
| functional delayed graft function group | patients with functional delayed graft function(fDGF) after kidney transplantation |
| |
| Normal | without functional kidney injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) | Diagnostic Test | Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with recovery of creatinine within 7 days less than 70%. | for renal transplantation patient | 1st month-12 month |
| Number of patients with allograft loss | for renal transplantation patient |
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
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, ①Obvious 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: ①Active 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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For A on C group:18-70 years old patient who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles, signed informed consent and with 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 fDGF in kidney transplantation patient :18-65 years old patient who can cooperate with breath-holding, breath-holding and breath-exhaling movements, and communicate without obstacles, signed informed consent and received Kidney transplant recipients in our hospital from May 2019 to November 2019.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
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(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 |
| 1st month-12 month |
| China-Japan Friendship Hospital | Beijing | China |
| ID | Term |
|---|---|
| D004194 | Disease |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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