- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03952689
Automatic Urine Output Measuring Device Performance Validation and Efficacy.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ramat Gan, Israel, 00000
- Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Post cardiac surgery patients
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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine volume measurement.
Time Frame: 24 hours
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Automatic device urine output measurement in compare with Urinometer
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute renal failure detection by urine output measurement and creatinine level in the blood.
Time Frame: 24 hours
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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.
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24 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eilon Ram, Dr, Sheba Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-19-5839-ER-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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