An observational study in Oliguria and Polyuria, sponsored by Potrero Medical. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-22.
Sponsored by Potrero Medical · Observational
Urine output and urine drain line pressure were monitored while urine was drained into either:
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.
14 studies on the registry are indexed under Polyuria; 2 are open to participants now.
Browse Polyuria studies →Potrero Medical is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
ICU patient that needs a Foley catheter
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Device: Accuryn
A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
Accuryn is a novel electronic urine output monitor
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.
Time frame: 2 - 5 days
| Milestone | Test- Accuryn Urine Output Monitor | Control- Critcore Urine Output Monitor |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| Patients with airlocks | Test- Accuryn Urine Output Monitor | Control- Critcore Urine Output Monitor |
|---|---|---|
| Urine Output of SOC Device Versus Accuryn | 0 (0 to 0) | 5 (5 to 5) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test- Accuryn Urine Output Monitor | — | — | — |
| Control- Critcore Urine Output Monitor | — | — | — |
| Age, Continuous(years) | Test- Accuryn Urine Output Monitor | Control- Critcore Urine Output Monitor | Total |
|---|---|---|---|
| Mean | 44 ± 22 | 52 ± 17.9 | 49 ± 20.2 |
| Sex: Female, Male(Participants) | Test- Accuryn Urine Output Monitor | Control- Critcore Urine Output Monitor | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 7 | 8 | 15 |
| Region of Enrollment(participants) | Test- Accuryn Urine Output Monitor | Control- Critcore Urine Output Monitor | Total |
|---|---|---|---|
| United States | 9 | 9 | 18 |
The record gives a start of Jul 2014, a primary completion of Feb 2015 and a completion of Feb 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2015, 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Potrero Medical