Endothelial Dysfunction in Perioperative Period

Postoperative Complications Clinical Trial

— EDOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014765
• Other study ID #: MZ 0120-446/2015-2
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: May 2018
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 8, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Postoperative Complications

Intervention

Other:
• EDOP
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Loyola University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction		12 months
Secondary	levels of blood circulating markers of increased perioperative stress and systemic inflammatory response	levels of vWF, selectin P, selectin E, IL-6, IL-8, IL-10, IL-18, TNFa	12 months
Secondary	decrease in endothelial function	reduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values	12 months