Acute Kidney Injury Clinical Trial
Official title:
Hand-carried Ultrasound for Ruling Out Hydronephrosis in Acute Kidney Injury and Acute Kidney Disease
Verified date | April 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates if trainees can accurately rule out dilation of the renal collecting system on ultrasound (hydronephrosis) using hand-carried ultrasound (HCU). Trainees will undergo a short ultrasound training program. Patients will be adults that are hospitalized and have acute or subacute kidney dysfunction. The investigators will assess sensitivity, specificity, positive and negative predictive value of HCU compared to radiology performed ultrasound, and calculate potential cost savings to the patient and to the healthcare system.
Status | Suspended |
Enrollment | 170 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age more than 18 years old - Inpatient admission to Barnes Jewish Hospital (BJH) - Patient has a diagnosis of Acute kidney injury (AKI) or Acute kidney Disease (AKD) - Renal ultrasound ordered or performed within the past 4 hours Exclusion Criteria: - End-stage renal disease - History of kidney transplant - Stable chronic kidney disease - Current diagnosis of renal cell carcinoma - Pregnant women - Morbid obesity (BMI >40) - Rash or active skin lesions overlying the scanning area (left or right flank) |
Country | Name | City | State |
---|---|---|---|
United States | Barnes Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Ultrasound image quality | Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist. | Through study completion, an average of 1 year | |
Other | Technical difficulty of the ultrasound study | How technically difficult was it for the trainees to obtain the images (patient intubated, obesity etc.) as graded by the trainees who performed the ultrasound scans themselves. Trainees will grade difficulty using the following measurement scale (1) Technically easy: trainee able to get clear images of both kidneys within a timeframe of 10 minutes (2) Technically challenging: Trainee able to get clear images of kidneys but requiring more than 10 minutes of scanning time (3) Technically difficult: trainee unable to get clear images of both kidneys independent of time spent scanning. | Through study completion, an average of 1 year | |
Primary | Absence of hydronephrosis | None of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system) | Through study completion, an average of 1 year | |
Secondary | Direct costs of hand-carried ultrasound | Direct costs in $ of hand-carried ultrasound will be calculated and compared to the costs of radiology performed ultrasound. For hand-carried ultrasound, this will include costs of purchasing the device, training costs, yearly depreciation of the hand-carried ultrasound device. For radiology performed ultrasound, this will include the sonographer's fee, radiologist fee for interpretation of the result, transportation fee by hospital transport and depreciation of the ultrasound machine. | 1 year |
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