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

November 29, 2023 updated by: Kyriakos K. Trigkidis, National and Kapodistrian University of Athens

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal intra-abdominal pressure
Diagnostic test: Abdominal ultrasound
Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score
Other Names:
  • VExUS score calculation
Elevated intra-abdominal pressure
Diagnostic test: Abdominal ultrasound
Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score
Other Names:
  • VExUS score calculation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Estimated)

December 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35656

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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