Clinical trial NCT03774719: Hand-carried Ultrasound to Assess Hydronephrosis
Official title: Hand-carried Ultrasound for Ruling Out Hydronephrosis in Acute Kidney Injury and Acute Kidney Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hydronephrosis
Ultrasound
Acute Kidney Injury
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Absence of Hydronephrosis
timeFrame: Through study completion, up to an average of 1 day
Secondary outcomes:
measure: Direct Costs of Hand-carried Ultrasound
timeFrame: Through study completion, up to an average of 1 day
Other outcomes:
measure: Ultrasound Image Quality
timeFrame: Through study completion, up to an average of 1 day
measure: Technical Difficulty of the Ultrasound Study
timeFrame: Through study completion, up to an average of 1 day
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
References: