Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FIZE kUO®.
- Who it may be relevant to
- Registry conditions: AKI - Acute Kidney Injury, Cardiac Surgery, Fluid Therapy, Hemodynamic Instability. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
FIZE kUO® Real-Time Measurement of Urine Output Response to Fluid Therapy and Diuretics in Cardiovascular Surgery Patients: A Prospective Post-Market Study
Overview
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
- 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.
Primary outcome measures
- Urine output response to fluid boluses and diuretics [Time frame: 4 hours (2 hours before and 2 hours after intervention)]
Secondary outcome measures (3)
- Difference in urine output during surgery between patients with and without AKI [Time frame: Perioperative/Periprocedural]
- Urine output response to vasopressors [Time frame: 4 hours (2 hours before and 2 hours after intervention)]
- Evaluation of FIZE kUO® Urine Output Monitoring Compared to Manual Measurement [Time frame: Through ICU stay, up to 5 days]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years and older scheduled for CABG or valve surgery and expected postoperative admission to CTICU
- Ability to provide informed consent
Exclusion criteria
- Pregnancy
- Preoperative dialysis (chronic or acute)
- Enrollment in other interventional trials assessing urine output or AKI
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Rabin Medical Center — Petah Tikva
Identifiers
NCT: NCT07022314 · FM-01