Ultrasound Markers of Systemic Inflammation

March 22, 2023 updated by: Osijek University Hospital

Ultrasound in the Intensive Care Unit and Measurable Indicators of Systemic Inflammation

The aim of this study was to measure whether the flow rate through the brachial artery and inflammatory markers were associated with the development of tissue edema in the surgical intensive care unit patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was performed using a ultrasound machine with linear probe settings at 50 mm depth and 40 decibel [dB] gain that did not change during the study. The probe was placed on vascular ultrasound measurement. The diameter of the brachial artery in the middle of the upper arm and the flow rate through the artery was measured on postoperative days 1 and 2. The presence of the edema was measured above the 3rd metacarpal bone as the distance from the skin surface to the periosteum. An average of three assessments was shown. Patient's age, body mass index (BMI), type of admission, white blood cells (WBC), C-reactive protein (CRP), and procalcitonin (PCT) were also registered.

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

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

Study Locations

  • Croatia
      • Osijek, Croatia, 31000
        • Slavica Kvolik

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients in Osijek University Hospital who are admitted in the ICU will be included in the study.

Description

Inclusion Criteria:

  • Adults over 18 years of age
  • Postoperative surgical patients
  • Signed informed consent

Exclusion Criteria:

  • Refusal to give informed consent
  • A previous thromboembolic event of the brachial artery
  • Acute infection of the upper extremity

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
ICU patients
Adult patients admitted to the ICU.
Diagnostic test: Ultrasound measurement
Study was conducted with Mindray T7 ultrasound machine using linear probe. Vascular ultrasound mode was used with settings depth of 50 mm and gain of 40 dB during the entire study period. The diameter and flow velocity of the brachial artery and wrist edema of the fist were measured within 24 hours of admission and the following day.
Other Names:
  • Mindray T7 ultrasound machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diameter of brachial artery - 1
Time Frame: within 4 hours of admission.
Measurement of a brachial artery diameter [cm] at admission. Admission day is considered as day 1.
within 4 hours of admission.
Diameter of brachial artery - 2
Time Frame: day 2 after admission is between 24 and 48 hours after admission.
measurement of a brachial artery diameter [cm] on day 2 after admission.
day 2 after admission is between 24 and 48 hours after admission.
Brachial artery flow velocity - 1
Time Frame: within 4 hours of admission to ICU.
measurement of a brachial artery flow velocity [cm/s] at admission.
within 4 hours of admission to ICU.
Brachial artery flow velocity - 2
Time Frame: day 2 after admission is between 24 and 48 hours after admission.
measurement of a brachial artery flow velocity [cm/s] on day 2 after admission. Day 2 is Measurement of a brachial artery flow velocity [cm/s] between 24 and 48 h after ICU admission.
day 2 after admission is between 24 and 48 hours after admission.
Distance from skin to third metacarpal bone -1
Time Frame: within 4 hours of admission.
measurement of a distance from the skin to third metacarpal bone (cm) at admission.
within 4 hours of admission.
Distance from skin to third metacarpal bone - 2
Time Frame: day 2 after admission is between 24 and 48 hours after admission.
measurement of a distance from the skin to third metacarpal bone (cm) on day 2 after admission.
day 2 after admission is between 24 and 48 hours after admission.
White blood cell count - 1
Time Frame: within 4 hours of admission.
blood sample analysis for white blood cell count (WBC [10^9/L]) at admission.
within 4 hours of admission.
White blood cell count - 2
Time Frame: day 2 after admission is between 24 and 48 hours after admission.
blood sample analysis for white blood cell count (WBC [10^9/L]) on day 2 after admission.
day 2 after admission is between 24 and 48 hours after admission.
C-reactive protein - 1
Time Frame: within 4 hours of admission.
blood sample analysis for C-reactive protein (CRP [mg/L]) concentration at admission.
within 4 hours of admission.
C-reactive protein - 2
Time Frame: day 2 after admission is between 24 and 48 hours after admission.
Blood sample analysis for C-reactive protein (CRP [mg/L]) concentration on day 2 after admission.
day 2 after admission is between 24 and 48 hours after admission.
Procalcitonin - 1
Time Frame: within 4 hours of admission.
blood sample analysis for Procalcitonin concentration (PCT [ug/L]) at admission.
within 4 hours of admission.
Procalcitonin - 2
Time Frame: Day 2 after admission is between 24 and 48 hours after admission.
Blood sample analysis for Procalcitonin concentration (PCT [ug/L]) on day 2 after admission.
Day 2 after admission is between 24 and 48 hours after admission.

Collaborators and Investigators

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

Sponsor

Osijek University Hospital

Collaborators

Josip Juraj Strossmayer University of Osijek

Investigators

  • Study Director: Slavica Kvolik, M.D., PhD,, Osijek University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2158-61-07-21-96

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Endothelial Dysfunction

Clinical Trials on Ultrasound measurement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe