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Completed

NCT Number: NCT05798182

Ultrasound Markers 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.

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Key information

Conditions

Inflammation Process Endothelial Dysfunction Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Swelling; Hand Vascular Dilation Vasomotor Arterial Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Slavica Kvolik

Osijek, 31000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound measurement

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. C-reactive protein - 1

    Time frame: within 4 hours of admission.

    blood sample analysis for C-reactive protein (CRP [mg/L]) concentration at admission.

  10. 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.

  11. Procalcitonin - 1

    Time frame: within 4 hours of admission.

    blood sample analysis for Procalcitonin concentration (PCT [ug/L]) at admission.

  12. 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.

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Collaborators

  • Josip Juraj Strossmayer University of Osijek

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 4, 2023
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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