An interventional study of Hand-carried ultrasound in Hydronephrosis, Ultrasound and Acute Kidney Injury, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Diagnostic
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.
Hand-carried ultrasound is an increasingly popular imaging modality and is widely used by emergency physicians, intensivists, trauma doctors and cardiologists. Renal ultrasonography is commonly ordered for patients with acute kidney injury, with a main focus on identifying obstruction of the collecting system, a rare but potentially reversible cause of acute kidney injury.
This study's aim is to evaluate if nephrology and internal medicine trainees can accurately rule out dilation of the renal collecting system on ultrasound (hydronephrosis) using hand-carried ultrasound (HCU). Trainees will undergo a short, uniform and well described 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.
55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.
This study's enrollment of 6 is below the median of 100 across 23 interventional studies indexed under Hydronephrosis.
Browse Hydronephrosis studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is the only arm of the study. It will be comprised of 154 inpatients who had a renal ultrasound ordered or performed within the past 4 hours. The intervention will be performing hand-carried ultrasound to evaluate for presence and degree of hydronephrosis.
Device: Hand-carried ultrasound
Hand-carried ultrasound of both kidneys to detect the presence or absence of hydronephrosis. Device used will be the lumify portable ultrasound equipped with the C5-2 curved array transducer (Philips, USA).
Also known as: Point of care ultrasound, POCUS
Number of Participants With Absence of Hydronephrosis
The number of participants for whom none of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system) is reported
Time frame: Through study completion, up to an average of 1 day
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.
Time frame: Through study completion, up to an average of 1 day
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.
Time frame: Through study completion, up to an average of 1 day
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.
Time frame: Through study completion, up to an average of 1 day
Participants were recruited after presenting to the hospital between May 2019 and April 2023. First participant was enrolled May 6, 2019 and last participant enrolled May 24, 2019.
| Milestone | Hand-carried Ultrasound Arm |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
The number of participants for whom none of the kidneys imaged with hand-carried ultrasound have hydronephrosis (dilation of the collecting system) is reported
| Participants | Hand-carried Ultrasound Arm |
|---|---|
| Number of Participants With Absence of Hydronephrosis | 4 |
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.
No measurements were reported for this outcome.
Ultrasound image quality assessed by a blinded independent radiologist. The quality will be deemed either excellent, good, fair or poor by the radiologist.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Time from start of ultrasound evaluation to end of ultrasound evaluation, up to 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hand-carried Ultrasound Arm | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Hand-carried Ultrasound Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 3 |
| Age, Continuous(years) | Hand-carried Ultrasound Arm |
|---|---|
| Median | 65.5 (60 to 67) |
| Sex: Female, Male(Participants) | Hand-carried Ultrasound Arm |
|---|---|
| Female | 2 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Hand-carried Ultrasound Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Hand-carried Ultrasound Arm |
|---|---|
| United States | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Jun 2021, 24 months.
Results were first posted in Jul 2024, 3 years 1 month after primary completion.
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