Endothelial Dysfunction in Perioperative Period (EDOP)
Primary Purpose
Endothelial Dysfunction, Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EDOP
Sponsored by
About this trial
This is an interventional diagnostic trial for Endothelial Dysfunction focused on measuring endothelial dysfunction, perioperative stress, cardiovascular complications, inflammatory markers
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
Sites / Locations
Outcomes
Primary Outcome Measures
rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction
Secondary Outcome Measures
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
decrease in endothelial function
reduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values
Full Information
NCT ID
NCT03014765
First Posted
January 4, 2017
Last Updated
May 2, 2018
Sponsor
University Medical Centre Ljubljana
Collaborators
Loyola University
1. Study Identification
Unique Protocol Identification Number
NCT03014765
Brief Title
Endothelial Dysfunction in Perioperative Period
Acronym
EDOP
Official Title
Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
Loyola University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Postoperative Complications
Keywords
endothelial dysfunction, perioperative stress, cardiovascular complications, inflammatory markers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
EDOP
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction
Time Frame
12 months
Secondary Outcome Measure Information:
Title
levels of blood circulating markers of increased perioperative stress and systemic inflammatory response
Description
levels of vWF, selectin P, selectin E, IL-6, IL-8, IL-10, IL-18, TNFa
Time Frame
12 months
Title
decrease in endothelial function
Description
reduction in dilatation capability of brachial artery in the perioperative period - the difference between preoperative and postoperative values
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Endothelial Dysfunction in Perioperative Period
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