Automatic Urine Output Measuring Device Performance Validation and Efficacy.

Not Applicable

• Conditions: Urine Output Decreased
• Interventions: Device: Serenno Medical Automatic Urine Output measuring device

• Registration Number: NCT03952689
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2019-05-14
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2021-10-14
• Study Completion: 2021-10-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post cardiac surgery patients	Serenno Medical Automatic Urine Output measuring device	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.

Primary Outcome Measures

Name	Time	Method
Urine volume measurement.	24 hours	Automatic device urine output measurement in compare with Urinometer

Secondary Outcome Measures

Name	Time	Method
Acute renal failure detection by urine output measurement and creatinine level in the blood.	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.

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Ramat Gan, Israel