Automated urIne Flow Detection to Reduce Errors and Nursing Workload

NCT03636113 | Completed

• 1 other identifier: PRO17030459
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an observational study which seeks to examine a) the accuracy of the Clarity Renal Monitoring System (Clarity RMS)® sensor kit at the bedside compared to manual urine output monitoring, b) total time/effort per patient with and without the device, c) the ease of use, clinical acceptance, and d) preliminary data on the detection of AKI using the Clarity RMS® sensor kit compared to standard care

Conditions

Acute Kidney Injury; Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Accuracy of the Clarity RMS® electronic sensor

  6-hour observation data, hourly urine output obtained from the EMR, and urine output monitoring captured by the Clarity RMS® electronic sensor

  6 hours after ICU admission

Study Arms (2)

ICU nurses -manual

Standard method of Urine Output monitoring

ICU nurses -automated

Device- Clarity RMS Electronic sensor

Device: Clarity RMS Electronic Sensor

Interventions

Clarity RMS Electronic Sensor DEVICE

The urinary foley catheter with electronic sensor will be placed within the Operating Room prior to surgery. Upon arrival to the ICU, the device will be connected to an electronic console by study coordinator. The study coordinator will weigh the urine drainage bag and record the weight every hour for 4-6 hours. The device will record urine flow on a 15 minute interval up to 6 hours

ICU nurses -automated

Eligibility Criteria

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

Study Population

ICU Nurses

You may qualify if:

• Male and Female ICU nurses
• Caring for 1 or more patients in ICU with a Foley catheter in situ

You may not qualify if:

• Nurse managing a patient who will be in ICU less than 4 hours
• Nurse managing a patient who is not producing urine

Sponsors & Collaborators

• University of Pittsburgh: lead
• RenalSense Ltd: collaborator

Study Sites (1)

UPMC Presbyterian Hosptial

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• John Kellum, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Vice Chair for Research

Study Record Dates

• First Submitted: August 4, 2018
• First Posted: August 17, 2018
• Study Start: July 11, 2018
• Primary Completion: December 28, 2018
• Study Completion: January 31, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

US (1)