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Clinical Trials/NCT03014765
NCT03014765
Completed
Not Applicable

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

University Medical Centre Ljubljana0 sites70 target enrollmentJanuary 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endothelial Dysfunction
Sponsor
University Medical Centre Ljubljana
Enrollment
70
Primary Endpoint
rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2017
End Date
December 8, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter Poredos

Head of Orthopaedic Anaesthesia

University Medical Centre Ljubljana

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

Outcomes

Primary Outcomes

rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction

Time Frame: 12 months

Secondary Outcomes

  • levels of blood circulating markers of increased perioperative stress and systemic inflammatory response(12 months)
  • decrease in endothelial function(12 months)

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