Diagnosis, Diagnostic Imaging, Kidney Disease
Conditions
Keywords
Ultrasound Elastography, Ultrasound Integrated Precision Diagnosis Technology, Acute on Chronic Kidney Disease, Kidney transplantation, kidney fibrosis
Brief 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.
Interventions
DIAGNOSTIC_TESTUltrasound 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
Sponsors
China-Japan Friendship Hospital
Duke University
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 <!-- --> 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of death | 1st month-12 month | for all patients |
| Number of patients with initiation of continuous renal replacement therapy | 1st month-12 month | for non-transplantation patient |
| Number of patients with creatinine increasing by more than 50% | 1st month-12 month | Number of patients with creatinine increasing by more than 50% of baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with new serious infections requiring hospitalization | 1st month-12 month | for all kidney injury |
| Number of patients with cardiovascular events | 1st month-12 month | (acute myocardial infarction, unstable angina pectoris, heart failure requiring hospitalization or death from cardiovascular diseases); |
| Number of patients with cerebrovascular events | 1st month-12 month | (cerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, transient ischemic attack or death from cerebrovascular diseases); |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with recovery of creatinine within 7 days less than 70%. | 1st month-12 month | for renal transplantation patient |
| Number of patients with allograft loss | 1st month-12 month | for renal transplantation patient |
Countries
China
Outcome results
None listed