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NCT06160856 Clinical Trial

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

Intra-Abdominal Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06160856
Other study ID # 35656
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date August 1, 2024

Study information
Verified date November 2023
Source National and Kapodistrian University of Athens
Contact Kyriakos K. Trigkidis, MD
Phone +30697843660
Email k.trigkidis@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 84
Est. completion date August 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Abdominal ultrasound
Measurement of venous congestion in abdominal target-organs (liver, kidneys) by calculating VExUS score

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National and Kapodistrian University of Athens

Outcome
Type Measure Description Time frame Safety issue
Primary VExUS score difference between the 2 study groups (normal and elevated intra-abdominal pressure) 01.12.2023 - 01.08.2024
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