EDOP
Otherno intervention
NCT Number: NCT03014765
Study will enroll patients scheduled for hip arthroplasty. In each subject a flow-mediated dilatation capability (FMD) of the brachial artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days after surgery. At each session the brachial artery diameter will be measured at rest, during cuff inflation and 50 seconds after cuff deflation. From above mentioned values the increase in the diameter of the artery during reactive hyperemia will be calculated.
Simultaneously with the ultrasound investigations, the blood for determination of the endothelial dysfunction markers will be collected.
The participants will be contacted again 3 months after the surgery and asked about the complications which may be associated with the surgery.
Looking for future studies?
Notify Me40 year–80 year
All sexes
Interventional
Not applicable
Cardiovascular complications, especially coronary heart disease, are one of the main causes of perioperative complications. Indicators of pre-clinical atherosclerosis, such as: endothelial dysfunction, increased arterial intima/media thickness (especially in the carotid arteries), carotid calcification and coronary calcification, suggest the presence of atherosclerotic process without the symptomatic presentation. Endothelial dysfunction is one of the earliest measurable changes that predict the development of atherosclerotic disease.
Surgery is a significant stress for the organism: it increases the release of free oxygen radicals and through oxidative stress it increases systemic inflammatory response and causes thromboembolic complications.
In the study 50 patients of both sexes 40-80 years of age scheduled for hip arthroplasty will be included. In each subject a flow-mediated dilatation capability (FMD) of the brachial artery will be measured prior to elective surgery, within 24 hours after surgery and 5-7 days after surgery. Measurement of the brachial artery flow-mediated dilatation capability (FMD): the brachial artery diameter will be measured 5 cm proximal to the antecubital fossa at rest, during cuff inflation and 50 seconds after cuff deflation. The cuff will be inflated for 4 min. From above mentioned values the increase in the diameter of the artery during reactive hyperemia will be calculated.
Simultaneously with the ultrasound investigations, the blood for determination of the inflammatory and endothelial dysfunction markers (CRP, IL-6, IL-8, IL-10, IL-18, TNFa, VW Factor, Selectin P, selectin E) will be collected.
The participants will be contacted again 3 months after the surgery and asked about the complications which may be associated with the surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
no intervention
Time frame: 12 months
Time frame: 12 months
levels of vWF, selectin P, selectin E, IL-6, IL-8, IL-10, IL-18, TNFa
Time frame: 12 months
reduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values
University Medical Centre Ljubljana
Other
Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period
Acronym: EDOP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03778307
Endothelial Dysfunction, Mental Disorders
Los Angeles, California, United States
View Trial DetailsNCT06472791
Endothelial Dysfunction
Portland, Oregon, United States
View Trial DetailsNCT07569744
Diabetes Mellitus, Diabetes Mellitus, Type 2
Palembang, South Sumatera, Indonesia
View Trial DetailsNCT05107869
Cardiovascular Diseases, Endothelial Dysfunction
Wauwatosa, Wisconsin, United States
View Trial Details