Back to resultsAutomatic Urine Output Measuring Device Performance Validation and Efficacy.
Primary Purpose
Urine Output Decreased
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Serenno Medical Automatic Urine Output measuring device
Sponsored by
About this trial
This is an interventional diagnostic trial for Urine Output Decreased
Eligibility Criteria
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.
Sites / Locations
- Sheba medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Post cardiac surgery patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Urine volume measurement.
Automatic device urine output measurement in compare with Urinometer
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03952689
Brief Title
Automatic Urine Output Measuring Device Performance Validation and Efficacy.
Official Title
Automatic Urine Output Measuring Device Performance Validation and Efficacy.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
October 14, 2021 (Anticipated)
Study Completion Date
October 14, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urine Output Decreased
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Observational, single arm test, self-controlled.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post cardiac surgery patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Serenno Medical Automatic Urine Output measuring device
Intervention Description
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).
Primary Outcome Measure Information:
Title
Urine volume measurement.
Description
Automatic device urine output measurement in compare with Urinometer
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Acute renal failure detection by urine output measurement and creatinine level in the blood.
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eilon Ram, Dr
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Ramat Gan
ZIP/Postal Code
00000
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Automatic Urine Output Measuring Device Performance Validation and Efficacy.
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