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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
University Medical Centre Ljubljana
About
Eligibility
Locations
Outcomes
Full info

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

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 4, 2017
    Last Updated
    May 2, 2018
    Sponsor
    University Medical Centre Ljubljana
    Collaborators
    Loyola University
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    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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