Clinical trial NCT04044404: Application of Ultrasound Integrated Precision Diagnosis Technology in Prevention of Kidney Disease and Its Progress
Official title: Application of Ultrasound Integrated Precision Diagnosis Technology in Prevention of Kidney Disease and Its Progress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Imaging
Diagnosis
Kidney Disease
Keywords: Ultrasound Elastography
Ultrasound Integrated Precision Diagnosis Technology
Acute on Chronic Kidney Disease
Kidney transplantation
kidney fibrosis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Duke University
First posted: 2019-08-05
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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.

Primary outcomes:
measure: Number of patients with creatinine increasing by more than 50%
timeFrame: 1st month-12 month
measure: Number of patients with initiation of continuous renal replacement therapy
timeFrame: 1st month-12 month
measure: Rate of death
timeFrame: 1st month-12 month
Secondary outcomes:
measure: Number of patients with cardiovascular events
timeFrame: 1st month-12 month
measure: Number of patients with cerebrovascular events
timeFrame: 1st month-12 month
measure: Number of patients with new serious infections requiring hospitalization
timeFrame: 1st month-12 month
Other outcomes:
measure: Number of patients with recovery of creatinine within 7 days less than 70%.
timeFrame: 1st month-12 month
measure: Number of patients with allograft loss
timeFrame: 1st month-12 month
Locations:
city: Shanghai
country: China
facility: Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
References: