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NCT Number: NCT04044404

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

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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Key information

Conditions

Diagnostic Imaging Diagnosis Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Disease Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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  • 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.

Treatment and study plan

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

Primary outcomes

  1. Number of patients with creatinine increasing by more than 50%

    Time frame: 1st month-12 month

    Number of patients with creatinine increasing by more than 50% of baseline.

  2. Number of patients with initiation of continuous renal replacement therapy

    Time frame: 1st month-12 month

    for non-transplantation patient

  3. Rate of death

    Time frame: 1st month-12 month

    for all patients

Secondary outcomes

  1. Number of patients with cardiovascular events

    Time frame: 1st month-12 month

    (acute myocardial infarction, unstable angina pectoris, heart failure requiring hospitalization or death from cardiovascular diseases);

  2. Number of patients with cerebrovascular events

    Time frame: 1st month-12 month

    (cerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke, transient ischemic attack or death from cerebrovascular diseases);

  3. Number of patients with new serious infections requiring hospitalization

    Time frame: 1st month-12 month

    for all kidney injury

Other outcomes

  1. Number of patients with recovery of creatinine within 7 days less than 70%.

    Time frame: 1st month-12 month

    for renal transplantation patient

  2. Number of patients with allograft loss

    Time frame: 1st month-12 month

    for renal transplantation patient

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Collaborators

  • China-Japan Friendship Hospital
  • Duke University

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2019
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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