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Inflammation ProcessNCT05798182

Ultrasound Markers of Systemic Inflammation

An observational study of Inflammation Process and Endothelial Dysfunction, run by Osijek University Hospital at 1 site in Croatia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ultrasound measurement
How many people
61 participants
Where
1 siteCroatia
Study dates
1 Dec 2020to 30 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • Slavica Kvolik

    Osijek, 31000

Other trials in Croatia

About this study

Official title: Ultrasound in the Intensive Care Unit and Measurable Indicators 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.

Read the 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.

Being tested
Ultrasound measurement
Keywords
Intensive Care, Surgical, Ultrasonography, Doppler, Inflammation
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound measurementDiagnostic test

    Also called Mindray T7 ultrasound machine

    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.

Study groups in NCT05798182
Study groupRoleWhat they receive
ICU patientsAdult patients admitted to the ICU.
Receives: Diagnostic Test: Ultrasound measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diameter of brachial artery - 1

    Measurement of a brachial artery diameter [cm] at admission. Admission day is considered as day 1.

    Measured: within 4 hours of admission.

  2. Diameter of brachial artery - 2

    measurement of a brachial artery diameter [cm] on day 2 after admission.

    Measured: day 2 after admission is between 24 and 48 hours after admission.

  3. Brachial artery flow velocity - 1

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

    Measured: within 4 hours of admission to ICU.

  4. 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.

    Measured: day 2 after admission is between 24 and 48 hours after admission.

  5. Distance from skin to third metacarpal bone -1

    measurement of a distance from the skin to third metacarpal bone (cm) at admission.

    Measured: within 4 hours of admission.

  6. 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.

    Measured: day 2 after admission is between 24 and 48 hours after admission.

  7. White blood cell count - 1

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

    Measured: within 4 hours of admission.

  8. White blood cell count - 2

    blood sample analysis for white blood cell count (WBC [10^9/L]) on day 2 after admission.

    Measured: day 2 after admission is between 24 and 48 hours after admission.

  9. C-reactive protein - 1

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

    Measured: within 4 hours of admission.

  10. C-reactive protein - 2

    Blood sample analysis for C-reactive protein (CRP [mg/L]) concentration on day 2 after admission.

    Measured: day 2 after admission is between 24 and 48 hours after admission.

  11. Procalcitonin - 1

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

    Measured: within 4 hours of admission.

  12. Procalcitonin - 2

    Blood sample analysis for Procalcitonin concentration (PCT [ug/L]) on day 2 after admission.

    Measured: Day 2 after admission is between 24 and 48 hours after admission.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start1 Dec 2020
  3. Primary completion30 Dec 2021
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05798182
Sponsor's protocol ID
2158-61-07-21-96
Status last verified
May 2021
First submitted
2 Jun 2022
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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/

  • 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

  • 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.

    PubMed 21733876

  • 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.

    PubMed 29467962

  • 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.

    PubMed 30356867

  • 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.

    PubMed 29706967

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

    PubMed 20349817

  • 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.

    PubMed 23727991

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammation Process and Endothelial Dysfunction, run by Osijek University Hospital at 1 site in Croatia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diameter of brachial artery - 1 (time frame: within 4 hours of admission.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05798182, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.

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