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

NCT04044404 | Completed DMC

• 2 other identifiers: RJ20180492019-52-K33
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 2

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.

Conditions

Diagnostic Imaging; Diagnosis; Kidney Disease

Keywords

Ultrasound Elastography; Ultrasound Integrated Precision Diagnosis Technology; Acute on Chronic Kidney Disease; Kidney transplantation; kidney fibrosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Number of patients with cardiovascular events

  1st month-12 month

• Number of patients with cerebrovascular events

  1st month-12 month

• Number of patients with new serious infections requiring hospitalization

  1st month-12 month

Other Outcomes (2)

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

  1st month-12 month

• Number of patients with allograft loss

  1st month-12 month

Study Arms (3)

A on C group

Acute on Chronic Kidney Disease patients

Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

functional delayed graft function group

patients with functional delayed graft function(fDGF) after kidney transplantation

Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

Normal

without functional kidney injury

Diagnostic Test: Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)

Interventions

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

A on C group; Normal; functional delayed graft function group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead
• China-Japan Friendship Hospital: collaborator
• Duke University: collaborator

Study Sites (2)

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

Shanghai, Shanghai Municipality, 200127, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

MeSH Terms

Conditions

Disease; Kidney Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: April 29, 2019
• Primary Completion: May 29, 2021
• Study Completion: June 30, 2021
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)