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

N/ANot Yet RecruitingNCT07022314

FIZE Medical ltd45 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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)

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