Urine Output DecreasedNCT03952689
Automatic Urine Output Measuring Device Performance Validation and Efficacy.
A study testing Serenno Medical Automatic Urine Output measuring device in people with Urine Output Decreased, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device in patients with indwelling urinary catheter hospitalized in the cardiac surgery intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urine Output Decreased
- What is being tested?
- Serenno Medical Automatic Urine Output measuring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 14 May 2019to 14 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Subjects, aged >18 years
- Patients hospitalized in the intensive care unit requiring an indwelling urinary catheter for urine output monitoring for at least 24 hours.
Who cannot join
- Known urological pathology including but not limited to nephrolithiasis, polycystic kidney disease, congenital abnormalities of the kidneys and or urinary tract, history of obstructive uropathy, advanced chronic kidney disease (stage 4) of any cause.
- Known pregnancy or lactating women.
- Cognitive and/or psychiatric impairment which may not allow cognitive signing on the informed consent unless patient has a legal representative that was appointed prior to patient enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device in patients with indwelling urinary catheter hospitalized in the cardiac surgery intensive care unit.
Read the detailed description
In order to evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device we will perform a non inferiority of study device in compare with Urinometer (with acceptance of 3% standard deviation), in patients hospitalized in the intensive care unit after cardiac surgery.
Secondary endpoints are to attribute and Identify urine output changes prior to early stage acute renal failure, and identifying urine output changes prior to fluid overload or dehydration.
- Conditions
- Urine Output Decreased
- Being tested
- Serenno Medical Automatic Urine Output measuring device
- Medical subject headings
- Oliguria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serenno Medical Automatic Urine Output measuring deviceDevice
Device that measures ongoing urine output will be connecter to the patients catheter. The urine count of the device will be compared to the "gold standard" measurement technique (nurse count).
| Study group | Role | What they receive |
|---|---|---|
| Post cardiac surgery patients | Experimental | For all patients, readings of the urine output from both the Serenno system and the collection bag (urinometer) (by camera) will be recorder every 10 minutes, for the duration of 24 hours. Receives: Device: Serenno Medical Automatic Urine Output measuring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine volume measurement.
Automatic device urine output measurement in compare with Urinometer
Measured: 24 hours
Secondary outcomes (1)
Acute renal failure detection by urine output measurement and creatinine level in the blood.
To identify urine output changes prior to early stage acute renal failure. Reduction in urine output in hemodynamic stable patients will be followed by creatinine measurement in the blood in order to verify laboratory signs of acute renal failure.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start14 May 2019
- Primary completion14 Oct 2021 (estimated)
- Study completion14 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Output DecreasedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Observational, single arm test, self-controlled.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eilon Ram, Dr, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952689
- Sponsor's protocol ID
- SHEBA-19-5839-ER-CTIL
- Status last verified
- Oct 2020
- First submitted
- 15 May 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Urine Output Measuring Device Performance Validation and Efficacy.
- ClinicalTrials.gov ID
- NCT03952689
- Acronym / sponsor ID
- SHEBA-19-5839-ER-CTIL
- Conditions
- Urine Output Decreased
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 14 May 2019 (actual)
- Primary completion
- 14 Oct 2021 (estimated)
- Study completion
- 14 Oct 2021 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device in patients with indwelling urinary catheter hospitalized in the cardiac surgery intensive care unit.
Detailed description
In order to evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device we will perform a non inferiority of study device in compare with Urinometer (with acceptance of 3% standard deviation), in patients hospitalized in the intensive care unit after cardiac surgery.
Secondary endpoints are to attribute and Identify urine output changes prior to early stage acute renal failure, and identifying urine output changes prior to fluid overload or dehydration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Observational, single arm test, self-controlled.
| Arm | Type | Receives |
|---|---|---|
| Post cardiac surgery patients | Experimental | Device: Serenno Medical Automatic Urine Output measuring deviceFor all patients, readings of the urine output from both the Serenno system and the collection bag (urinometer) (by camera) will be recorder every 10 minutes, for the duration of 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects, aged >18 years
- Patients hospitalized in the intensive care unit requiring an indwelling urinary catheter for urine output monitoring for at least 24 hours.
Key exclusion criteria (3 listed)
- Known urological pathology including but not limited to nephrolithiasis, polycystic kidney disease, congenital abnormalities of the kidneys and or urinary tract, history of obstructive uropathy, advanced chronic kidney disease (stage 4) of any cause.
- Known pregnancy or lactating women.
- Cognitive and/or psychiatric impairment which may not allow cognitive signing on the informed consent unless patient has a legal representative that was appointed prior to patient enrollment.
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 |
|---|---|---|
| Serenno Medical Automatic Urine Output measuring deviceDevice that measures ongoing urine output will be connecter to the patients catheter. The urine count of the device will be compared to the "gold standard" measurement technique (nurse count). | Device | Post cardiac surgery patients |
Primary outcome
Urine volume measurement.
Time frame: 24 hours
Automatic device urine output measurement in compare with Urinometer
1 secondary outcome
Acute renal failure detection by urine output measurement and creatinine level in the blood.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Urine Output Decreased
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.
Eilon Ram, Dr principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serenno Medical Automatic Urine Output measuring device in people with Urine Output Decreased, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
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 volume measurement. (time frame: 24 hours). 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 Oct 2020.