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Endothelial Dysfunction in Perioperative Period

Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03014765
Acronym
EDOP
Enrollment
70
Registered
2017-01-09
Start date
2017-01-03
Completion date
2017-12-08
Last updated
2018-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Postoperative Complications

Keywords

endothelial dysfunction, perioperative stress, cardiovascular complications, inflammatory markers

Brief summary

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.

Detailed description

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.

Interventions

OTHEREDOP

no intervention

Sponsors

Loyola University
CollaboratorOTHER
University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* scheduled hip arthroplasty under spinal anesthesia

Exclusion criteria

* Acute coronary syndrome or cerebrovascular syndrome in the last 6 months * Acute venous thrombosis in the last 6 months * Episode of rheumatoid arthritis in the last 3 months or permanent therapy with prednisolone \>4mg/day * Acute illness or hospitalization in the last month * Chronic kidney failure on dialysis * Hepatic failure * Active malignant disease * Immunosuppression after organ transplantation * Pregnancy * No informed consent after oral and written information

Design outcomes

Primary

MeasureTime frame
rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction12 months

Secondary

MeasureTime frameDescription
levels of blood circulating markers of increased perioperative stress and systemic inflammatory response12 monthslevels of vWF, selectin P, selectin E, IL-6, IL-8, IL-10, IL-18, TNFa
decrease in endothelial function12 monthsreduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026