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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post cardiac surgery patients | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serenno Medical Automatic Urine Output measuring device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Urine volume measurement. | Automatic device urine output measurement in compare with Urinometer | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eilon Ram, Dr | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba medical center | Ramat Gan | 00000 | Israel |
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| ID | Term |
|---|---|
| D009846 | Oliguria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Prospective Observational, single arm test, self-controlled.
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |