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Automatic Urine Output Measuring Device Performance Validation and Efficacy.

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ClinicalTrials.gov Identifier: NCT03952689
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urine Output Decreased Device: Serenno Medical Automatic Urine Output measuring device Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Observational, single arm test, self-controlled.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Automatic Urine Output Measuring Device Performance Validation and Efficacy.
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : October 14, 2021
Estimated Study Completion Date : October 14, 2021

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Arms and Interventions
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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.
 Device: Serenno Medical Automatic Urine Output measuring device
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).


Outcome Measures
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Primary Outcome Measures :
  1. Urine volume measurement. [ Time Frame: 24 hours ]
    Automatic device urine output measurement in compare with Urinometer


Secondary Outcome Measures :
  1. Acute renal failure detection by urine output measurement and creatinine level in the blood. [ Time Frame: 24 hours ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952689


Locations
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Israel
Sheba medical center
Ramat Gan, Israel, 00000
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Eilon Ram, Dr Sheba Medical Center
More Information
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03952689    
Other Study ID Numbers: SHEBA-19-5839-ER-CTIL
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oliguria
Urination Disorders
Urologic Diseases
Urological Manifestations