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Endothelial Dysfunction in Perioperative Period (EDOP)

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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Postoperative Complications Other: EDOP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endothelial Dysfunction, Indicator of Perioperative Complications and Its Changes in Perioperative Period
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : June 16, 2017
Actual Study Completion Date : December 8, 2017
Arms and Interventions
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Intervention Details:
  • Other: EDOP
    no intervention

Outcome Measures
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Primary Outcome Measures :
  1. rate of perioperative cardiovascular complications in patients scheduled for hip arthroplasty under spinal anesthesia related to endothelial dysfunction [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Peter Poredos, Head of Orthopaedic Anaesthesia, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03014765    
Other Study ID Numbers: MZ 0120-446/2015-2
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter Poredos, University Medical Centre Ljubljana:
endothelial dysfunction
perioperative stress
cardiovascular complications
inflammatory markers
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes