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.

Study Overview

• Status: Completed
• Conditions: Diagnosis; Diagnostic Imaging; Kidney Disease
• Intervention / Treatment: Diagnostic test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • China-Japan Friendship Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Department of nephrology , Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	(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

Other Outcome Measures

Outcome Measure	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	1st month-12 month

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Duke University; China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): May 29, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Kidney transplantation; Ultrasound Elastography; Ultrasound Integrated Precision Diagnosis Technology; Acute on Chronic Kidney Disease; kidney fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Disease
• Other Study ID Numbers: RJ2018049; 2019-52-K33 (Other Identifier: China-Japan Friendship Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No