Shear Wave Elastography in Differentiating Acute or Chronic Kidney Disease (CKD-SWE)

August 15, 2023 updated by: National Taiwan University Hospital
Chronic kidney disease is a common global public health issue and its prevalence increased year by year. Early diagnosis and intervention can prevent further complications and comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve the patients' life quality. To differentiate acute from chronic kidney disease was crucial especially in the setting of crowded and high-risk emergency department. To diagnose acute or chronic kidney disease, physicians usually use blood sample test combined with image studies such as conventional sonography, CT and MRI. However, there was lots of limited factors. The patients may have no previous visit records, poor renal function to receive contrast medium, or critical clinical condition to undergo time-wasting exam. Although the conventional renal sonography is accessible and inexpensive, the judgement is subjective and provide little clinical information. Recent researches of shear wave elastography in evaluating renal parenchymal stiffness showed some correlation with nephropathy. In our study, aiming to facilitating clinical implication, the investigators will use swear-wave elastography combined with conventional renal sonography to benefit patients in diagnosis of acute or chronic kidney disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a case-control study. The investigators obtained data from participants who were older than 20 years old and received renal sonography examination in the emergency department of National Taiwan University Hospital. The investigators examined the participants' kidneys by recording the kidney size, cortical thickness, possible lesions and elasticity by shear-wave elastography. These data combined with the participants' medical history and renal function revealed by blood examination will be analyzed. This study was designed to determine the correlation between renal cortical elasticity and chronic kidney disease.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Sub-Investigator:
          • Jia-Yu Chen, MD.
        • Sub-Investigator:
          • An-bu Lee, MD.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Approximately 400 patients with normal kidney function and 400 patients with abnormal kidney function

Description

Inclusion Criteria:

  • The patients older than 20 years old who needed to receive renal sonography in emergency department of National Taiwan University Hospital.

Exclusion Criteria:

  • The patients who didn't obtain agreement.
  • The patients who can't cooperate or follow the directions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal renal function
Diagnostic test: Shear wave elastography to distinguish AKI from normal kidney
Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
Acute kidney injury in normal kidney
Diagnostic test: Shear wave elastography to distinguish AKI from normal kidney
Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
Acute kidney injury in chronic kidney disease
Diagnostic test: Shear wave elastography to distinguish AKI from CKD
Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
Chronic kidney disease
Diagnostic test: Shear wave elastography to distinguish CKD from normal kidney
Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the correlation of kPa ratio and renal function in chronic renal disease
Time Frame: change in renal function after 2 weeks
The analysis will be conducted to determine the correlation between kPa ratio measured by elastography and renal function in patients with chronic renal disease
change in renal function after 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001091RINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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