Automatic Urine Output Measuring Device Performance Validation and Efficacy.
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|ClinicalTrials.gov Identifier: NCT03952689|
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urine Output Decreased||Device: Serenno Medical Automatic Urine Output measuring device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective Observational, single arm test, self-controlled.|
|Masking:||None (Open Label)|
|Official Title:||Automatic Urine Output Measuring Device Performance Validation and Efficacy.|
|Actual Study Start Date :||May 14, 2019|
|Estimated Primary Completion Date :||May 14, 2020|
|Estimated Study Completion Date :||May 14, 2020|
Experimental: Post cardiac surgery patients
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.
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).
- Urine volume measurement. [ Time Frame: 24 hours ]Automatic device urine output measurement in compare with Urinometer
- Acute renal failure detection by urine output measurement and creatinine level in the blood. [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952689
|Contact: Eilon Ram, Dr||526669119 ext +firstname.lastname@example.org|
|Sheba medical center||Recruiting|
|Ramat Gan, Israel, 00000|
|Contact: Alexander Kogan, DR Alexander.email@example.com|
|Principal Investigator:||Eilon Ram, Dr||Sheba Medical Center|