Urine Output Decreased
Conditions
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.
Interventions
DEVICESerenno 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).
Sponsors
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective Observational, single arm test, self-controlled.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine volume measurement. | 24 hours | Automatic device urine output measurement in compare with Urinometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Israel
Outcome results
None listed