Hand-carried Ultrasound to Assess Hydronephrosis

NCT03774719 | Terminated Results DMC FDA Device

• 1 other identifier: 201903192-1985080800
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydronephrosis; Ultrasound; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, up to an average of 1 day

Secondary Outcomes (1)

• Direct Costs of Hand-carried Ultrasound

  Through study completion, up to an average of 1 day

Other Outcomes (2)

• Ultrasound Image Quality

  Through study completion, up to an average of 1 day

• Technical Difficulty of the Ultrasound Study

  Through study completion, up to an average of 1 day

Study Arms (1)

Hand-carried ultrasound arm

EXPERIMENTAL

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

Interventions

Hand-carried ultrasound DEVICE

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

Hand-carried ultrasound arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hydronephrosis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency

Limitations and Caveats

Single center, study terminated did not reach enrollment target due to change in PI and COVID pandemic. No statistical analysis was performed.

Results Point of Contact

• Title: Gonzalo Matzumura
• Organization: Washington University in Saint Louis

g.matzumuraumemoto@wustl.edu

3143627211

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 13, 2018
• Study Start: May 6, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2023
• Last Updated: July 24, 2024
• Results First Posted: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)