Trials / Not Yet Recruiting
Not Yet RecruitingNCT07022314
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
FIZE kUO® Real-Time Measurement of Urine Output Response to Fluid Therapy and Diuretics in Cardiovascular Surgery Patients: A Prospective Post-Market Study
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 45 (estimated)
- Sponsor
- FIZE Medical ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- AKI - Acute Kidney Injury
- Cardiac Surgery
- Fluid Therapy
- Hemodynamic Instability
- Postoperative Complications
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FIZE kUO® | 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. |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2025-06-15
- Last updated
- 2025-06-15
Locations
1 site across 1 country: Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07022314. Inclusion in this directory is not an endorsement.