Ultrasound Markers of Systemic Inflammation

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05798182
• Other study ID #: 2158-61-07-21-96
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Inflammation
• Vascular Dilation

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.