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

NCT07022314 | Not Yet Recruiting FDA Device

• 1 other identifier: FM-01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

AKI - Acute Kidney Injury; Cardiac Surgery; Fluid Therapy; Hemodynamic Instability; Postoperative Complications

Keywords

FIZE kUO; Urine Output; Fluid Management; Diuretics; Cardiothoracic Surgery

Outcome Measures

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.

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

Secondary Outcomes (3)

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

  Perioperative/Periprocedural

• Urine output response to vasopressors

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

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

  Through ICU stay, up to 5 days

Study Arms (1)

Cardiothoracic ICU Patients

Adult patients (≥18 years old) undergoing coronary artery bypass graft (CABG) and/or valve surgery, admitted postoperatively to the Cardiothoracic Intensive Care Unit (CTICU), and connected to the FIZE kUO® device for real-time urine output monitoring as part of standard care.

Device: FIZE kUO®

Interventions

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.

Cardiothoracic ICU Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Adults aged 18 years and older scheduled for CABG or valve surgery and expected postoperative admission to CTICU
• Ability to provide informed consent

You may not qualify if:

• Pregnancy
• Preoperative dialysis (chronic or acute)
• Enrollment in other interventional trials assessing urine output or AKI

Sponsors & Collaborators

• FIZE Medical ltd: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Acute Kidney Injury; Postoperative Complications

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rinat Kalaora

CONTACT

+972-544-750887; rinat.kalaora@fizemedcial.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-05

Locations

IL (1)