Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07022314

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

AKI - Acute Kidney Injury Acute Kidney Injury Cardiac Surgery Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fluid Therapy Hemodynamic Instability Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rabin Medical Center

Petah Tikva, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Urine output response to fluid boluses and diuretics

    Time frame: 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 outcomes

  1. Difference in urine output during surgery between patients with and without AKI

    Time frame: Perioperative/Periprocedural

    Comparison of urine output measured by FIZE kUO® in patients who develop AKI vs. those who do not

  2. Urine output response to vasopressors

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

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

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

    Time frame: Through ICU stay, up to 5 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Rinat Kalaora

CONTACT

[email protected]

+972-544-750887

Sponsors and collaborators

Lead sponsor

FIZE Medical ltd

Industry

Registry information

Official study title

FIZE kUO® Real-Time Measurement of Urine Output Response to Fluid Therapy and Diuretics in Cardiovascular Surgery Patients: A Prospective Post-Market Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.