Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

NCT02195713 | Completed Results DMC

• 1 other identifier: PM-JMSRF2014-BCF01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Urine output and urine drain line pressure were monitored while urine was drained into either:

1. 1.Accuryn Urine Output Monitor (Potrero Medical) OR
2. 2.Criticore Monitor (Bard Medical)

Conditions

Oliguria; Polyuria

Outcome Measures

Primary Outcomes (1)

• Urine Output of SOC Device Versus Accuryn

  Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.

  2 - 5 days

Study Arms (2)

Test- Accuryn Urine Output Monitor

Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.

Device: Accuryn

Control- Critcore Urine Output Monitor

A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.

Interventions

Accuryn DEVICE

Accuryn is a novel electronic urine output monitor

Test- Accuryn Urine Output Monitor

Eligibility Criteria

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

Study Population

ICU patient that needs a Foley catheter

You may qualify if:

• Patient must ≥ 18 years of age
• Patient has a Foley catheter and urine collection system is in place per standard clinical decision
• Estimated length of placement of the Foley is 48 hours minimum
• Burn injury ≥ 20% and ≤ 80% total body surface area (TBSA)
• Subject or subject's legally authorized representative is able to give informed consent before entering the study

You may not qualify if:

• Currently pregnant or breastfeeding
• Clinical signs or symptoms of a urinary tract infection (UTI)
• Clinical signs or symptoms of a vaginal infection
• Currently has bladder or urethral trauma
• Use of investigational drug/device therapy within the past 4 weeks

Sponsors & Collaborators

• Potrero Medical: lead

Study Sites (2)

Joseph M. Still Burn Center at Doctors Hospital

Augusta, Georgia, 30909, United States

Location

The University of Texas Medical Branch (UTMBP)

Galveston, Texas, 77555, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Oliguria; Polyuria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Devyani Nanduri
• Organization: Theranova, LLC

dnanduri@theranova.com

415-926-8616

Study Officials

• George Kramer

  UTMB

  PRINCIPAL INVESTIGATOR

• Bruce Friedman

  Joseph M. Stills Burn Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 22, 2016
• Results First Posted: September 1, 2015

Record last verified: 2016-01

Locations

US (2)