OliguriaNCT02195713
Evaluation of a Novel Electronic Urine Output Monitor (eUOM)
An observational study of Oliguria and Polyuria, run by Potrero Medical at 2 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Accuryn
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Feb 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patient that needs a Foley catheter
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joseph M. Still Burn Center at Doctors Hospital
Augusta, Georgia, 30909
The University of Texas Medical Branch (UTMBP)
Galveston, Texas, 77555
About this study
Urine output and urine drain line pressure were monitored while urine was drained into either:
- Accuryn Urine Output Monitor (Potrero Medical) OR
- Criticore Monitor (Bard Medical)
Read the 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 commercially available system (Criticore, Bard Medical) when used with a standard Foley catheter and standard urinary drainage tube.
- Being tested
- Accuryn
- Medical subject headings
- Oliguria, Polyuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccurynDevice
Accuryn is a novel electronic urine output monitor
| Study group | Role | What they receive |
|---|---|---|
| Test- Accuryn Urine Output Monitor | Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 - 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OliguriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Potrero Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Kramer, Principal investigator, UTMBBruce Friedman, Principal investigator, Joseph M. Stills Burn Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195713
- Sponsor's protocol ID
- PM-JMSRF2014-BCF01
- Status last verified
- Jan 2016
- First submitted
- 15 Jul 2014
- Last updated
- 22 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Electronic Urine Output Monitor (eUOM)
- ClinicalTrials.gov ID
- NCT02195713
- Acronym / sponsor ID
- PM-JMSRF2014-BCF01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Potrero MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Posted 1 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urine output and urine drain line pressure were monitored while urine was drained into either:
- Accuryn Urine Output Monitor (Potrero Medical) OR
- 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 commercially available system (Criticore, Bard Medical) when used with a standard Foley catheter and standard urinary drainage tube.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test- Accuryn Urine Output Monitor | – | Device: AccurynAccuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patient that needs a Foley catheter
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccurynAccuryn is a novel electronic urine output monitor | Device | Test- Accuryn Urine Output Monitor |
Primary outcome
Urine Output of SOC Device Versus Accuryn
Time frame: 2 - 5 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Oliguria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Kramer principal investigator
UTMB
Bruce Friedman principal investigator
Joseph M. Stills Burn Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oliguria and Polyuria, run by Potrero Medical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Output of SOC Device Versus Accuryn (time frame: 2 - 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.