Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFIZE Medical ltd

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Cardiothoracic ICU Patients1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 hours (2 hours before and 2 hours after intervention)

Secondary outcomes

1

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

Time frame
Perioperative/Periprocedural
2

Urine output response to vasopressors

Change in urine output measured by FIZE kUO® before and after vasopressor administration

Time frame
4 hours (2 hours before and 2 hours after intervention)
3

Evaluation of FIZE kUO® Urine Output Monitoring Compared to Manual Measurement

Comparison of FIZE kUO® urine output with manual measurement of urine output

Time frame
Through ICU stay, up to 5 days

Other outcomes

Sponsors and contacts

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