NCT04404114

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Feb 2020Dec 2026

Study Start

First participant enrolled

February 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 18, 2025

Status Verified

October 1, 2025

Enrollment Period

6.9 years

First QC Date

April 28, 2020

Last Update Submit

November 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine the correlation of kPa ratio and renal function in chronic renal disease

    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

Study Arms (4)

Normal renal function

Normal renal function

Diagnostic Test: Shear wave elastography to distinguish AKI from normal kidney

Acute kidney injury in normal kidney

Acute kidney injury in normal kidney

Diagnostic Test: Shear wave elastography to distinguish AKI from normal kidney

Acute kidney injury in chronic kidney disease

Acute kidney injury in chronic kidney disease

Diagnostic Test: Shear wave elastography to distinguish AKI from CKD

Chronic kidney disease

Chronic kidney disease

Diagnostic Test: Shear wave elastography to distinguish CKD from normal kidney

Interventions

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 kidneyNormal renal function

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

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jia Yu Chen, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2020

First Posted

May 27, 2020

Study Start

February 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 18, 2025

Record last verified: 2025-10

Locations