AKI - Acute Kidney InjuryNCT07022314
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
An observational study of AKI - Acute Kidney Injury and Cardiac Surgery, run by FIZE Medical ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury, Cardiac Surgery, Fluid Therapy
- What is being tested?
- FIZE kUO®
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults aged 18 years and older scheduled for CABG or valve surgery and expected postoperative admission to CTICU
- Ability to provide informed consent
Who cannot join
- Pregnancy
- Preoperative dialysis (chronic or acute)
- Enrollment in other interventional trials assessing urine output or AKI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- AKI - Acute Kidney Injury, Cardiac Surgery, Fluid Therapy, Hemodynamic Instability, Postoperative Complications
- Being tested
- FIZE kUO®
- Keywords
- FIZE kUO, Urine Output, Fluid Management, Diuretics, Cardiothoracic Surgery
- Medical subject headings
- Acute Kidney Injury, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FIZE kUO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Comparison of urine output measured by FIZE kUO® in patients who develop AKI vs. those who do not
Measured: Perioperative/Periprocedural
Urine output response to vasopressors
Change in urine output measured by FIZE kUO® before and after vasopressor administration
Measured: 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
Measured: Through ICU stay, up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FIZE Medical ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022314
- Sponsor's protocol ID
- FM-01
- Status last verified
- Aug 2026
- First submitted
- 4 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07022314
- Acronym / sponsor ID
- FM-01
- Conditions
- AKI - Acute Kidney Injury, Cardiac Surgery, Fluid Therapy, Hemodynamic Instability, Postoperative Complications
- Keywords
- FIZE kUO, Urine Output, Fluid Management, Diuretics, Cardiothoracic Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- FIZE Medical ltdIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiothoracic ICU Patients | – | Device: FIZE kUO®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Adults aged 18 years and older scheduled for CABG or valve surgery and expected postoperative admission to CTICU
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Preoperative dialysis (chronic or acute)
- Enrollment in other interventional trials assessing urine output or AKI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Cardiothoracic ICU Patients |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AKI - Acute Kidney Injury and Cardiac Surgery, run by FIZE Medical ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rinat Kalaora (+972-544-750887, rinat.kalaora@fizemedcial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine output response to fluid boluses and diuretics (time frame: 4 hours (2 hours before and 2 hours after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.