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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05798182
Other study ID # 2158-61-07-21-96
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 30, 2021

Study information

Verified date May 2021
Source Osijek University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Croatia Slavica Kvolik Osijek

Sponsors (2)

Lead Sponsor Collaborator
Osijek University Hospital Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

References & Publications (8)

Cavka A, Tadžic R, Grizelj I, Unfirer S, Mihaljevic Z, Mihalj M et al. Endotelna funkcija - funkcionalni pokazatelj kardiovaskularnih rizicnih cimbenika. Medicinski vjesnik [Internet]. 2012 [Accessed 23.05.2021.];44((1-4)):135-146. Available from: https://hrcak.srce.hr/187756

Chakraborty RK, Burns B. Systemic Inflammatory Response Syndrome. [Updated 2021 Jul 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547669/

Chen L, Deng H, Cui H, Fang J, Zuo Z, Deng J, Li Y, Wang X, Zhao L. Inflammatory responses and inflammation-associated diseases in organs. Oncotarget. 2017 Dec 14;9(6):7204-7218. doi: 10.18632/oncotarget.23208. eCollection 2018 Jan 23. — View Citation

Evans DH. Colour flow and motion imaging. Proc Inst Mech Eng H. 2010;224(2):241-53. doi: 10.1243/09544119JEIM599. — View Citation

Kubler A, Maciejewski D, Adamik B, Kaczorowska M. Mechanical ventilation in ICUs in Poland: a multi-center point-prevalence study. Med Sci Monit. 2013 Jun 3;19:424-9. doi: 10.12659/MSM.883930. — View Citation

Lu D, Kassab GS. Role of shear stress and stretch in vascular mechanobiology. J R Soc Interface. 2011 Oct 7;8(63):1379-85. doi: 10.1098/rsif.2011.0177. Epub 2011 Jul 6. — View Citation

Mortaz E, Alipoor SD, Adcock IM, Mumby S, Koenderman L. Update on Neutrophil Function in Severe Inflammation. Front Immunol. 2018 Oct 2;9:2171. doi: 10.3389/fimmu.2018.02171. eCollection 2018. — View Citation

Sproston NR, Ashworth JJ. Role of C-Reactive Protein at Sites of Inflammation and Infection. Front Immunol. 2018 Apr 13;9:754. doi: 10.3389/fimmu.2018.00754. eCollection 2018. — View Citation

Outcome

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