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This prospective observational study evaluates the real-time urine output response to fluid therapy and diuretics in cardiothoracic intensive care unit (CTICU) patients monitored with the FIZE kUO® device. The study aims to assess how continuous urine output monitoring can inform fluid management and improve patient outcomes post-cardiac surgery.
The study involves adult patients undergoing coronary artery bypass graft (CABG) or valve replacement/repair surgeries. Utilizing the FIZE kUO® device, continuous urine output data will be collected to analyze responses to hemodynamic interventions, including fluid boluses and diuretics. Secondary objectives include assessing urine output differences in patients with and without postoperative acute kidney injury (AKI), responses to vasopressors, and capturing real-time urine output data from FIZE kUO® for observational analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiothoracic ICU Patients | Adult patients (≥18 years old) undergoing coronary artery bypass graft (CABG) and/or valve surgery, admitted postoperatively to the Cardiothoracic Intensive Care Unit (CTICU), and connected to the FIZE kUO® device for real-time urine output monitoring as part of standard care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIZE kUO® | Device | FIZE kUO® is a commercially available, non-invasive device used for continuous, minute-by-minute real-time urine output monitoring in patients with an indwelling Foley catheter. In this observational study, the device is used during and after cardiac surgery as part of routine clinical care. Urine output data, along with additional clinical parameters, are collected throughout the study for research analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Urine output response to fluid boluses and diuretics | Change in urine output measured by FIZE kUO® during 2 hours before and after fluid or diuretic administration. | 4 hours (2 hours before and 2 hours after intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in urine output during surgery between patients with and without AKI | Comparison of urine output measured by FIZE kUO® in patients who develop AKI vs. those who do not | Perioperative/Periprocedural |
| Urine output response to vasopressors |
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Inclusion Criteria:
Exclusion Criteria:
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Adult cardiac surgery patients in the cardiothoracic ICU who require continuous urine output monitoring and are connected to the FIZE kUO® device as part of routine clinical care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rinat Kalaora | Contact | +972-544-750887 | rinat.kalaora@fizemedcial.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Change in urine output measured by FIZE kUO® before and after vasopressor administration
| 4 hours (2 hours before and 2 hours after intervention) |
| Evaluation of FIZE kUO® Urine Output Monitoring Compared to Manual Measurement | Comparison of FIZE kUO® urine output with manual measurement of urine output | Through ICU stay, up to 5 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |