Status:
COMPLETED
Evaluation of a Novel Electronic Urine Output Monitor (eUOM)
Lead Sponsor:
Potrero Medical
Conditions:
Oliguria
Polyuria
Eligibility:
All Genders
18+ years
Brief Summary
Urine output and urine drain line pressure were monitored while urine was drained into either: 1. Accuryn Urine Output Monitor (Potrero Medical) OR 2. Criticore Monitor (Bard Medical)
Detailed Description
The purpose of this study is to determine the characteristics of urine output and drain line pressure as measured with the Accuryn urinary output monitoring system and urine output as recorded by a co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02195713
Start Date
July 1 2014
End Date
February 1 2015
Last Update
February 22 2016
Active Locations (2)
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1
Joseph M. Still Burn Center at Doctors Hospital
Augusta, Georgia, United States, 30909
2
The University of Texas Medical Branch (UTMBP)
Galveston, Texas, United States, 77555