Cardiac and Aortic SurgeryVExUS-CSNCT07183397
Impact of Fluid Resuscitation on Venous Congestion in Cardiac Critically-ill Patients
An observational study of Cardiac and Aortic Surgery and Cardiac Anaesthesia, run by Medical University of Vienna.
Trial summary
The objective of this study is to assess how fluid resuscitation, in the context of fluid responsiveness, affects the incidence and progression of systemic venous congestion in critically ill cardiac patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac and Aortic Surgery, Cardiac Anaesthesia, Venous Congestion
- What is being tested?
- VExUS & Cardiac Ultrasound
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to Dec 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: Cardiac critically ill patients (mainly post cardiac surgery)
Who may be able to join
- Age above 18 years
- Admission to cardiac intensive care unit
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The objective of this study is to assess how fluid resuscitation, in the context of fluid responsiveness, affects the incidence and progression of systemic venous congestion in critically ill cardiac patients. Additionally, the study aims to evaluate the impact on clinical outcomes, with a particular focus on acute kidney dysfunction. This assessment will utilize the VExUS score in conjunction with comprehensive bedside echocardiographic evaluations.
- Being tested
- VExUS & Cardiac Ultrasound
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VExUS & Cardiac UltrasoundDiagnostic test
The VExUS system provides a semi-quantitative assessment of systemic venous congestion by integrating ultrasound evaluations of the inferior vena cava diameter, hepatic vein flow, portal pulsatility, and renal venous flow, offering a practical and comprehensive bedside tool
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous congestion
Venous congestion as assessed by the VExUS score at ICU admission, and on each of the first seven postoperative days.
Measured: 7 days
Acute kidney injury
Acute kidney injury (AKI), defined through the KDIGO criteria, within seven and twenty-eight days of ICU admission.
Measured: Twenty-eight days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac and Aortic SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro D. Wendel Garcia, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183397
- Sponsor's protocol ID
- 1706/2025
- Acronym
- VExUS-CS
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is available upon reasonable request and after the approval of the Steering Committee members.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fluid Resuscitation on Venous Congestion in Cardiac Critically-ill Patients
- ClinicalTrials.gov ID
- NCT07183397
- Acronym / sponsor ID
- VExUS-CS / 1706/2025
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 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.
The objective of this study is to assess how fluid resuscitation, in the context of fluid responsiveness, affects the incidence and progression of systemic venous congestion in critically ill cardiac patients. Additionally, the study aims to evaluate the impact on clinical outcomes, with a particular focus on acute kidney dysfunction. This assessment will utilize the VExUS score in conjunction with comprehensive bedside echocardiographic evaluations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac critically ill patients (mainly post cardiac surgery)
Key inclusion criteria (2 listed)
- Age above 18 years
- Admission to cardiac intensive care unit
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VExUS & Cardiac UltrasoundThe VExUS system provides a semi-quantitative assessment of systemic venous congestion by integrating ultrasound evaluations of the inferior vena cava diameter, hepatic vein flow, portal pulsatility, and renal venous flow, offering a practical and comprehensive bedside tool | Diagnostic test | – |
Primary outcome
Venous congestion
Time frame: 7 days
Venous congestion as assessed by the VExUS score at ICU admission, and on each of the first seven postoperative days.
Acute kidney injury
Time frame: Twenty-eight days
Acute kidney injury (AKI), defined through the KDIGO criteria, within seven and twenty-eight days of ICU admission.
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 19 Sep 2025.
- Individual participant dataSharing planned: Undecided. Data is available upon reasonable request and after the approval of the Steering Committee members.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac and Aortic Surgery and Cardiac Anaesthesia, run by Medical University of Vienna.
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 0 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: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Pedro D Wendel Garcia, Dr. med. (+4369981577596, pedro.wendelgarcia@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous congestion (time frame: 7 days). The study lists 2 primary outcomes in all. 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 19 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.