Intra-Abdominal HypertensionNCT06160856
Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.
An observational study of Intra-Abdominal Hypertension and Venous Congestion, run by National and Kapodistrian University of Athens.
Trial summary
The goal of this prospective observational study is to examine the potential association between intra-abdominal pressure and venous congestion as assessed by abdominal ultrasound, in critically ill patients in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Hypertension, Venous Congestion
- What is being tested?
- Abdominal ultrasound
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Consecutive adult patients admitted in a 31-bed University-affiliated general ICU in a tertiary hospital (Evangelismos General Hospital, Athens, Greece). The ICU admitts both medical and surgical patients.
Who may be able to join
- Intubated ICU patients on controlled mechanical ventilation, receiving sedation. Patients must have urethral catheter in place.
Who cannot join
- age < 18 year old
- pregnancy / lactation
- primary liver disease (hepatic cirrhosis, hepatic space-occupying lesions, Budd-Chiari syndrome, portal vein thrombosis) or hepatic surgery
- end stage renal failure or on chronic dialysis
- non-intubated patients or intubated patients on non-controlled mechanical ventilation mode
- absence of urethral catheter, presence of suprapubic catheter, continuous bladder irrigation
- poor abdominal echogenicity
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this prospective observational study is to examine the potential association between intra-abdominal pressure and venous congestion as assessed by abdominal ultrasound, in critically ill patients in the Intensive Care Unit (ICU).
The main question it aims to answer is whether there is association between intra-abdominal pressure and Venous Excess Ultrasound (VExUS) score.
Participants will be sonographically assessed and their intra-abdominal pressure measured once within the first 3 days of ICU admission.
- Conditions
- Intra-Abdominal Hypertension, Venous Congestion
- Being tested
- Abdominal ultrasound
- Medical subject headings
- Intra-Abdominal Hypertension, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasoundDiagnostic test
Also called VExUS score calculation
Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score
| Study group | Role | What they receive |
|---|---|---|
| Normal intra-abdominal pressure | Not described Receives: Diagnostic Test: Abdominal ultrasound | |
| Elevated intra-abdominal pressure | Not described Receives: Diagnostic Test: Abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
VExUS score difference between the 2 study groups (normal and elevated intra-abdominal pressure)
Measured: 01.12.2023 - 01.08.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal HypertensionStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyriakos K. Trigkidis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160856
- Sponsor's protocol ID
- 35656
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.
- ClinicalTrials.gov ID
- NCT06160856
- Acronym / sponsor ID
- 35656
- Conditions
- Intra-Abdominal Hypertension, Venous Congestion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 7 Dec 2023 (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 goal of this prospective observational study is to examine the potential association between intra-abdominal pressure and venous congestion as assessed by abdominal ultrasound, in critically ill patients in the Intensive Care Unit (ICU).
The main question it aims to answer is whether there is association between intra-abdominal pressure and Venous Excess Ultrasound (VExUS) score.
Participants will be sonographically assessed and their intra-abdominal pressure measured once within the first 3 days of ICU admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal intra-abdominal pressure | – | Diagnostic Test: Abdominal ultrasound |
| Elevated intra-abdominal pressure | – | Diagnostic Test: Abdominal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients admitted in a 31-bed University-affiliated general ICU in a tertiary hospital (Evangelismos General Hospital, Athens, Greece). The ICU admitts both medical and surgical patients.
Key inclusion criteria (1 listed)
- Intubated ICU patients on controlled mechanical ventilation, receiving sedation. Patients must have urethral catheter in place.
Key exclusion criteria (7 listed)
- age < 18 year old
- pregnancy / lactation
- primary liver disease (hepatic cirrhosis, hepatic space-occupying lesions, Budd-Chiari syndrome, portal vein thrombosis) or hepatic surgery
- end stage renal failure or on chronic dialysis
- non-intubated patients or intubated patients on non-controlled mechanical ventilation mode
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 |
|---|---|---|
| Abdominal ultrasoundAlso: VExUS score calculationMeasurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score | Diagnostic test | Elevated intra-abdominal pressure, Normal intra-abdominal pressure |
Primary outcome
VExUS score difference between the 2 study groups (normal and elevated intra-abdominal pressure)
Time frame: 01.12.2023 - 01.08.2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra-Abdominal Hypertension and Venous Congestion, run by National and Kapodistrian University of Athens.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyriakos K. Trigkidis, MD (+30697843660, k.trigkidis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VExUS score difference between the 2 study groups (normal and elevated intra-abdominal pressure) (time frame: 01.12.2023 - 01.08.2024). 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 7 Dec 2023.