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

NCT06160856 | Unknown

• 1 other identifier: 35656
• Study Type: observational
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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

Intra-Abdominal Hypertension; Venous Congestion

Outcome Measures

Primary Outcomes (1)

• VExUS score difference between the 2 study groups (normal and elevated intra-abdominal pressure)

  01.12.2023 - 01.08.2024

Study Arms (2)

Normal intra-abdominal pressure

Diagnostic Test: Abdominal ultrasound

Elevated intra-abdominal pressure

Diagnostic Test: Abdominal ultrasound

Interventions

Abdominal ultrasound DIAGNOSTIC_TEST

Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score

Also known as: VExUS score calculation

Elevated intra-abdominal pressure; Normal intra-abdominal pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Hyperemia

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kyriakos K. Trigkidis, MD

CONTACT

+30697843660; k.trigkidis@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-11