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Clinical Trials/NCT04152395
NCT04152395
Unknown
N/A

Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

University of Thessaly0 sites220 target enrollmentJune 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
University of Thessaly
Enrollment
220
Primary Endpoint
Mortality
Last Updated
5 years ago

Overview

Brief Summary

This prospective study aims to identify the prevalence of metabolic syndrome in patients undergoing EVAR and the implications of metabolic syndrome on the postoperative outcome, the major complications, the thromboembolic events and the perioperative mortality and morbidity of the patients undergoing vascular surgery.

Detailed Description

Patients scheduled for elective EVAR will be randomly divided in two groups. One group patients with metabolic syndrome and one without. Metabolic syndrome is defined by the definition of 2009 as: Increased waist circumflex (\>94 cm in men and \> 80 cm in women), increased triglycerides or in therapy, decreased HDL (\< 40 mg/dl in men and \<50mg/dl in women) or in therapy, Increased blood pressure (Systolic Blood Pressure\>130 mmHg or Diastolic Blood Pressure\>85 mmHg) or in therapy, increased fasting glucose (\>100mg/dl) or in therapy. All the patients will be monitored throughout the perioperative period, at 30 days, 6 and 12 months, and any major or minor complication will be recorded.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
December 11, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elena Arnaoutoglou

Professor of Anesthesiology

University of Thessaly

Eligibility Criteria

Inclusion Criteria

  • elective EVAR

Exclusion Criteria

  • Patients incapable to give informed consent
  • Pregnancy
  • Systematic Inflammatory disease
  • Use of steroids
  • Emergency surgery
  • Prior ICU admission

Outcomes

Primary Outcomes

Mortality

Time Frame: 12 months

Patients after EVAR who died in 12 months

Secondary Outcomes

  • Systematic inflammatory response(12 months)
  • Postimplantation syndrome(12 months)
  • Renal insufficiency(12 months)
  • Cardiovascular events(12 months)
  • Thromboembolic events(12 months)
  • Complications of surgical procedure(12 months)

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