Acute Kidney Disease, Chronic Kidney Disease
Conditions
Keywords
kidney disease, fibrosis, ultrasound, elastography
Brief summary
In this proposal, the aim is to examine shear wave elastography (SWE) measurements in diseased native kidneys and correlate them with grades of fibrosis using histological samples. The overall goals of the proposed study are addressed by the following specific aim. Specific aim: To determine whether differences exist in elasticity measurements between native kidneys with and without fibrosis. Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue elasticity and stiffness compared to kidneys with zero fibrosis.
Detailed description
The proposed project is a prospective cross-sectional study correlating native kidney shear wave elastography (SWE) measurements with histology. Briefly, patients referred for a native kidney biopsy will undergo SWE and the shear wave velocity (SWV) will be correlated with degree of fibrosis determined by a pathologist. A list of patients who recently underwent a native kidney biopsy will be obtained from the pathology department on a weekly basis. Patients will then be contacted about participating in the study and consented during a follow up visit with their nephrologist. After their biopsies, patients will be scheduled to come for a renal ultrasound and SWE. SWE examination will be conducted using an ultrasound machine equipped with a Philips Epiq ARFI Shear wave ElastPQ C1-5 mHz transducer. Shear wave velocity will be obtained and an estimate of tissue elasticity (Young's modulus) will be calculated. All measurements will be performed by one of two qualified radiology physicians who will be blinded to the clinical and pathological data. We will allow a period of 90 days to obtain the images after the biopsy; otherwise the patient is no longer eligible to participate. The primary outcome measure of this study is to determine whether tissue elasticity determined by SWE can assess kidney fibrosis. Linear regression analysis will be performed to describe the relation of the extent of fibrosis and parenchymal stiffness.
Interventions
DEVICEShear wave elastography
Ultrasound technique of the kidneys to assess wave elastography.
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients over 18 years of age who are referred for a native kidney biopsy.
Exclusion criteria
* BMI \> 35 * Patients with polycystic kidney disease, renal cell carcinoma, hydronephrosis or renal stones. * Patients who develop severe post biopsy complications (infection, significant bleeding requiring transfusion or intervention) * Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shear Wave Velocity of Kidney Parenchyma | 6 months | The shear wave velocity of the kidneys will be determined using the elastography ultrasound machine. This will enable us to calculate the tissue elasticity using a standard formula. Shear wave velocity is measured in meters per second, at a range of 0-5 m/s with the highest number reporting hard consistency (fibrosis - worse outcome). |
Countries
United States
Participant flow
Recruitment details
Outpatient
Participants by arm
| Arm | Count |
|---|---|
| Shear Wave Elastography Group Patients referred for kidney biopsy will then undergo shear wave elastography measurements.
Shear wave elastography: Ultrasound technique of the kidneys to assess wave elastography. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Shear Wave Elastography Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 52.1 years |
| Race/Ethnicity, Customized African American | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Shear Wave Velocity of Kidney Parenchyma
The shear wave velocity of the kidneys will be determined using the elastography ultrasound machine. This will enable us to calculate the tissue elasticity using a standard formula. Shear wave velocity is measured in meters per second, at a range of 0-5 m/s with the highest number reporting hard consistency (fibrosis - worse outcome).
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Shear Wave Elastography Group | Shear Wave Velocity of Kidney Parenchyma | 0.21 meters per second | Standard Deviation 0.71 |