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Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)

Sponsor
University of Thessaly (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04152395
Collaborator
(none)
220
Enrollment
30.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: EVAR

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
220 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Study of Metabolic Syndrome in Patients Undergoing Endovascular Aortic Repair (EVAR)
Anticipated Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Dec 11, 2021
Anticipated Study Completion Date :
Dec 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Metabolic group

Patients with metabolic syndrome undergoing EVAR

Other: EVAR
Patients undergoing EVAR
Control group

Patients without metabolic syndrome undergoing EVAR

Other: EVAR
Patients undergoing EVAR

Outcome Measures

Primary Outcome Measures

  1. Mortality [30 days]

    Patients after EVAR who died in 30 days

  2. Mortality [6 months]

    Patients after EVAR who died in 6 months

  3. Mortality [12 months]

    Patients after EVAR who died in 12 months

Secondary Outcome Measures

  1. Systematic inflammatory response [30 days]

    Patients after EVAR that develop Systematic inflammatory response

  2. Systematic inflammatory response [6 months]

    Patients after EVAR that develop Systematic inflammatory response

  3. Systematic inflammatory response [12 months]

    Patients after EVAR that develop Systematic inflammatory response

  4. Postimplantation syndrome [30 days]

    Patients after EVAR that develop Postimplantation syndrome

  5. Postimplantation syndrome [6 months]

    Patients after EVAR that develop Postimplantation syndrome

  6. Postimplantation syndrome [12 months]

    Patients after EVAR that develop Postimplantation syndrome

  7. Renal insufficiency [30 days]

    Patients after EVAR that develop Renal insufficiency

  8. Renal insufficiency [6 months]

    Patients after EVAR that develop Renal insufficiency

  9. Renal insufficiency [12 months]

    Patients after EVAR that develop Renal insufficiency

  10. Cardiovascular events [30 days]

    Incidence of cardiovascular events in patients after EVAR

  11. Cardiovascular events [6 months]

    Incidence of cardiovascular events in patients after EVAR

  12. Cardiovascular events [12 months]

    Incidence of cardiovascular events in patients after EVAR

  13. Thromboembolic events [30 days]

    Incidence of thromboembolic events in patients after EVAR

  14. Thromboembolic events [6 months]

    Incidence of thromboembolic events in patients after EVAR

  15. Thromboembolic events [12 months]

    Incidence of thromboembolic events in patients after EVAR

  16. Complications of surgical procedure [30 days]

    Incidence of Complications of surgical procedure

  17. Complications of surgical procedure [6 months]

    Incidence of Complications of surgical procedure

  18. Complications of surgical procedure [12 months]

    Incidence of Complications of surgical procedure

Other Outcome Measures

  1. Postoperative delirium (POD) [30 days, 6 and 12 months]

    Prevalence of POD in patients undergoing EVAR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • elective EVAR
Exclusion Criteria:

  • Patients incapable to give informed consent

  • Pregnancy

  • Cancer

  • Systematic Inflammatory disease

  • Use of steroids

  • Emergency surgery

  • Prior ICU admission

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Thessaly

Investigators

  • Study Chair: Elena Arnaoutoglou, MD, PhD, University of Thessaly
  • Study Director: Haralampos Milionis, MD, PhD, University of Ioannina
  • Principal Investigator: Konstantina Kolonia, MD, PhD, University Hospital of Larissa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
ClinicalTrials.gov Identifier:
NCT04152395
Other Study ID Numbers:
  • Metabolic syndrome in EVAR
First Posted:
Nov 5, 2019
Last Update Posted:
May 27, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly
Metabolic Syndrome
EVAR
Additional relevant MeSH terms:
Metabolic Syndrome
Syndrome

Study Results

No Results Posted as of May 27, 2020