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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04044404
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
China-Japan Friendship Hospital
Duke University
Information provided by (Responsible Party):
RenJi Hospital

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.


Condition or disease Intervention/treatment
Diagnostic Imaging Diagnosis Kidney Disease Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Ultrasound Integrated Precision Diagnosis Technology in Prevention of Kidney Disease and Its Progress
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : May 29, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
A on C group
Acute on Chronic Kidney Disease patients
Diagnostic Test: Ultrasound 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

functional delayed graft function group
patients with functional delayed graft function(fDGF) after kidney transplantation
Diagnostic Test: Ultrasound 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

Normal
without functional kidney injury
Diagnostic Test: Ultrasound 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044404


Locations
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China, Shanghai
Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: shan mou, Dr.    13918221242    shan_mou@126.com   
Principal Investigator: shan mou, Dr.         
China
China-Japan Friendship Hospital Not yet recruiting
Beijing, China
Contact: Min Zhen, MD    13910251652    zhenmin16@163.com   
Sponsors and Collaborators
RenJi Hospital
China-Japan Friendship Hospital
Duke University
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04044404    
Other Study ID Numbers: RJ2018049
2019-52-K33 ( Other Identifier: China-Japan Friendship Hospital )
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
Ultrasound Elastography
Ultrasound Integrated Precision Diagnosis Technology
Acute on Chronic Kidney Disease
Kidney transplantation
kidney fibrosis
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases