AKI - Acute Kidney Injury, Cardiac Surgery, Fluid Therapy, Hemodynamic Instability, Postoperative Complications
Conditions
Keywords
FIZE kUO, Urine Output, Fluid Management, Diuretics, Cardiothoracic Surgery
Brief 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.
Interventions
DEVICEFIZE 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.
Sponsors
FIZE Medical ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years and older scheduled for CABG or valve surgery and expected postoperative admission to CTICU 2. Ability to provide informed consent
Exclusion criteria
1. Pregnancy 2. Preoperative dialysis (chronic or acute) 3. Enrollment in other interventional trials assessing urine output or AKI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine output response to fluid boluses and diuretics | 4 hours (2 hours before and 2 hours after intervention) | Change in urine output measured by FIZE kUO® during 2 hours before and after fluid or diuretic administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in urine output during surgery between patients with and without AKI | Perioperative/Periprocedural | Comparison of urine output measured by FIZE kUO® in patients who develop AKI vs. those who do not |
| Urine output response to vasopressors | 4 hours (2 hours before and 2 hours after intervention) | Change in urine output measured by FIZE kUO® before and after vasopressor administration |
| Evaluation of FIZE kUO® Urine Output Monitoring Compared to Manual Measurement | Through ICU stay, up to 5 days | Comparison of FIZE kUO® urine output with manual measurement of urine output |
Countries
Israel
Contacts
CONTACTRinat Kalaora
Outcome results
None listed