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Endothelial Dysfunction in Perioperative Period (EDOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 4, 2017
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date May 8, 2018
Actual Study Start Date  ICMJE January 3, 2017
Actual Primary Completion Date June 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endothelial Dysfunction in Perioperative Period
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Endothelial Dysfunction
  • Postoperative Complications
Intervention  ICMJE Other: EDOP
no intervention
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
50
Actual Study Completion Date  ICMJE December 8, 2017
Actual Primary Completion Date June 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014765
Other Study ID Numbers  ICMJE MZ 0120-446/2015-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peter Poredos, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Loyola University
Investigators  ICMJE Not Provided
PRS Account University Medical Centre Ljubljana
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP