NCT05798182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
Last Updated

April 4, 2023

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

June 2, 2022

Last Update Submit

March 22, 2023

Conditions

Inflammation ProcessEndothelial DysfunctionVasomotor Arterial DisorderVascular DilationSwelling; Hand

Keywords

Intensive Care, SurgicalUltrasonography, DopplerInflammation

Outcome Measures

Primary Outcomes (12)

  • 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.

  • 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.

  • Brachial artery flow velocity - 1

    measurement of a brachial artery flow velocity \[cm/s\] at admission.

    within 4 hours of admission to ICU.

  • 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.

  • 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.

  • 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.

  • White blood cell count - 1

    blood sample analysis for white blood cell count (WBC \[10\^9/L\]) at admission.

    within 4 hours of admission.

  • 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.

  • C-reactive protein - 1

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

    within 4 hours of admission.

  • 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.

  • Procalcitonin - 1

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

    within 4 hours of admission.

  • 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.

Study Arms (1)

ICU patients

Adult patients admitted to the ICU.

Diagnostic Test: Ultrasound measurement

Interventions

Ultrasound measurementDIAGNOSTIC_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.

Also known as: Mindray T7 ultrasound machine
ICU patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Slavica Kvolik

Osijek, 31000, Croatia

Location

Related Publications (8)

  • 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/

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 21733876BACKGROUND

  • 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.

    PMID: 29467962BACKGROUND

  • 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.

    PMID: 30356867BACKGROUND

  • 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.

    PMID: 29706967BACKGROUND

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

    PMID: 20349817BACKGROUND

  • 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.

    PMID: 23727991BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Slavica Kvolik, M.D., PhD,

    Osijek University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

April 4, 2023

Study Start

December 1, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

April 4, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)