Clinical trial NCT03014765: Endothelial Dysfunction in Perioperative Period
Official title: Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Postoperative Complications
Keywords: endothelial dysfunction
perioperative stress
cardiovascular complications
inflammatory markers
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Loyola University
First posted: 2017-01-09
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction
timeFrame: 12 months
Secondary outcomes:
measure: levels of blood circulating markers of increased perioperative stress and systemic inflammatory response
timeFrame: 12 months
measure: decrease in endothelial function
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: