Not yet recruitingNCT06160856Updated Dec 7, 2023

Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.

An observational study in Intra-Abdominal Hypertension and Venous Congestion, sponsored by National and Kapodistrian University of Athens. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by National and Kapodistrian University of Athens · Observational

From the registry’s dates

Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 84
Ages: 18 Years and older
Sex: All

Study 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).

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 studied

Intra-Abdominal Hypertension
Venous Congestion

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In context

Intra-Abdominal Hypertension

71 studies on the registry are indexed under Intra-Abdominal Hypertension; 16 are open to participants now.

This study's planned enrollment of 84 is below the median of 98 across 36 observational studies indexed under Intra-Abdominal Hypertension.

Browse Intra-Abdominal Hypertension studies →

Lead sponsor

National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Intubated ICU patients on controlled mechanical ventilation, receiving sedation. Patients must have urethral catheter in place.

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 84 participants (estimated)
Patient registry: No

Groups and cohorts

Normal intra-abdominal pressure
Diagnostic Test: Abdominal ultrasound
Elevated intra-abdominal pressure
Diagnostic Test: Abdominal ultrasound

Interventions

Diagnostic testAbdominal ultrasound
Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score
Also known as: VExUS score calculation

What researchers measure

Primary outcomes

VExUS score difference between the 2 study groups (normal and elevated intra-abdominal pressure)
Time frame: 01.12.2023 - 01.08.2024

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2023; primary completion for Jun 2024, 6 months later.

Of 20 observational studies under Intra-Abdominal Hypertension, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 26. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 29, 2023
First posted: Dec 7, 2023
StartEst.: Dec 1, 2023
Primary completionEst.: Jun 1, 2024
CompletionEst.: Aug 1, 2024
Last update: Dec 7, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06160856
Lead sponsor: National and Kapodistrian University of Athens
Responsible party: Kyriakos K. Trigkidis (Dr, National and Kapodistrian University of Athens) — Principal investigator
First posted: Dec 7, 2023
Start date: Dec 1, 2023 (estimated)
Primary completion: Jun 1, 2024 (estimated)
Completion: Aug 1, 2024 (estimated)
Last update: Dec 7, 2023

Study contacts

Kyriakos K. Trigkidis, MD

Contact

k.trigkidis@gmail.com

+30697843660

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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