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Clinical Trials/NCT05798182
NCT05798182
Completed
Not Applicable

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

Osijek University Hospital1 site in 1 country61 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inflammation Process
Sponsor
Osijek University Hospital
Enrollment
61
Locations
1
Primary Endpoint
Brachial artery flow velocity - 1
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
December 30, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Osijek University Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Procalcitonin - 1

Time Frame: within 4 hours of admission.

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

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.

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.

C-reactive protein - 1

Time Frame: within 4 hours of admission.

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

Study Sites (1)

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