NCT03952689

Automatic Urine Output Measuring Device Performance Validation and Efficacy.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urine Output Decreased

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-05-14
• Primary completion: 2021-10-14
• Completion: 2021-10-14
• First posted: 2019-05-16
• Last updated: 2020-10-22

Locations

1 site across 1 country: Israel