Clinical Trials Logo

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.
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Completed NCT04156711 - Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery N/A
Recruiting NCT06133634 - Fisetin to Improve Vascular Function in Older Adults Phase 1/Phase 2
Completed NCT05872139 - Role of Mitochondrial-derived Oxidative Stress to Promote Vascular Endothelial Dysfunction in Non-exercisers With Aging N/A
Recruiting NCT04558450 - Covid-19 Effects on Arterial Stiffness and Vascular Aging (CARTESIAN) N/A
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Not yet recruiting NCT05939934 - Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Recruiting NCT02334839 - The Association Between Severity of Hypertensive Disorder During Pregnancy and Endothelial Dysfunction N/A
Recruiting NCT02020044 - Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) N/A
Completed NCT01775865 - Targeting Inflammation to Treat Cardiovascular Aging Phase 2
Completed NCT01691404 - Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure (FLAVO) N/A
Terminated NCT01412216 - The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance Phase 2
Completed NCT01319344 - Effect of Eplerenone on Endothelial Function in Metabolic Syndrome Phase 3
Completed NCT00848302 - Endothelial Function in Human Arteries Early Phase 1
Completed NCT00987974 - Short Term Statin Treatment and Endothelial Dysfunction Due to Ischemia and Reperfusion Injury Phase 4
Completed NCT00990730 - Atherosclerosis in Rheumatoid Arthritis N/A
Completed NCT00532844 - A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction Phase 2
Completed NCT00376246 - Effect of Ezetimibe on Flow-mediated Brachial Artery Reactivity in Healthy Subjects Phase 4
Completed NCT00775099 - Combustion Derived Air Pollution and Vascular Function N/A