Endothelial Dysfunction in Perioperative Period (EDOP)

• ClinicalTrials.gov Identifier: NCT03014765
• Recruitment Status: Completed
• First Posted: January 9, 2017
• Last Update Posted: May 8, 2018
• Sponsor: University Medical Centre Ljubljana
• Collaborator: Loyola University
• Information provided by (Responsible Party): Peter Poredos, University Medical Centre Ljubljana

Tracking Information

• First Submitted Date: January 4, 2017
• First Posted Date: January 9, 2017
• Last Update Posted Date: May 8, 2018
• Actual Study Start Date: January 3, 2017
• Actual Primary Completion Date: June 16, 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 5, 2017): rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 5, 2017)

• levels of blood circulating markers of increased perioperative stress and systemic inflammatory response [ Time Frame: 12 months ]
  levels of vWF, selectin P, selectin E, IL-6, IL-8, IL-10, IL-18, TNFa
• decrease in endothelial function [ Time Frame: 12 months ]
  reduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Endothelial Dysfunction in Perioperative Period
• Official Title: Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Endothelial Dysfunction
• Postoperative Complications

Intervention

Other: EDOP

no intervention

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 2, 2018): 70
• Original Estimated Enrollment (submitted: January 5, 2017): 50
• Actual Study Completion Date: December 8, 2017
• Actual Primary Completion Date: June 16, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03014765
• Other Study ID Numbers: MZ 0120-446/2015-2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Peter Poredos, University Medical Centre Ljubljana
• Study Sponsor: University Medical Centre Ljubljana
• Collaborators: Loyola University
• Investigators: Not Provided
• PRS Account: University Medical Centre Ljubljana
• Verification Date: May 2018