About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years and older scheduled for CABG or valve surgery and expected postoperative admission to CTICU
Ability to provide informed consent
Disqualifiers
Pregnancy
Preoperative dialysis (chronic or acute)
Enrollment in other interventional trials assessing urine output or AKI
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
FIZE kUO®
DeviceFIZE 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
Urine output response to vasopressors
Change in urine output measured by FIZE kUO® before and after vasopressor administration
Evaluation of FIZE kUO® Urine Output Monitoring Compared to Manual Measurement
Comparison of FIZE kUO® urine output with manual measurement of urine output
Sponsors and contacts
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