Automatic Urine Output Measuring Device Performance Validation and Efficacy.

Urine Output Decreased Clinical Trial

Official title:

Automatic Urine Output Measuring Device Performance Validation and Efficacy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952689
• Other study ID #: SHEBA-19-5839-ER-CTIL
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: October 14, 2021

Study information

• Verified date: October 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oliguria
• Urine Output Decreased

Intervention

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).

Locations

Country	Name	City	State
Israel	Sheba medical center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine volume measurement.	Automatic device urine output measurement in compare with Urinometer	24 hours
Secondary	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.	24 hours