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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04152395
Other study ID # Metabolic syndrome in EVAR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date December 11, 2022

Study information

Verified date May 2020
Source University of Thessaly
Contact Konstantina Kolonia, MD
Phone +306958261393
Email kon.kolonia@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 220
Est. completion date December 11, 2022
Est. primary completion date December 11, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
EVAR
Patients undergoing EVAR

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Thessaly

References & Publications (4)

Aguilar M, Bhuket T, Torres S, Liu B, Wong RJ. Prevalence of the metabolic syndrome in the United States, 2003-2012. JAMA. 2015 May 19;313(19):1973-4. doi: 10.1001/jama.2015.4260. — View Citation

Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Associa — View Citation

Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. — View Citation

Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Bloo — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Postoperative delirium (POD) Prevalence of POD in patients undergoing EVAR 30 days, 6 and 12 months
Primary Mortality Patients after EVAR who died in 30 days 30 days
Primary Mortality Patients after EVAR who died in 6 months 6 months
Primary Mortality Patients after EVAR who died in 12 months 12 months
Secondary Systematic inflammatory response Patients after EVAR that develop Systematic inflammatory response 30 days
Secondary Systematic inflammatory response Patients after EVAR that develop Systematic inflammatory response 6 months
Secondary Systematic inflammatory response Patients after EVAR that develop Systematic inflammatory response 12 months
Secondary Postimplantation syndrome Patients after EVAR that develop Postimplantation syndrome 30 days
Secondary Postimplantation syndrome Patients after EVAR that develop Postimplantation syndrome 6 months
Secondary Postimplantation syndrome Patients after EVAR that develop Postimplantation syndrome 12 months
Secondary Renal insufficiency Patients after EVAR that develop Renal insufficiency 30 days
Secondary Renal insufficiency Patients after EVAR that develop Renal insufficiency 6 months
Secondary Renal insufficiency Patients after EVAR that develop Renal insufficiency 12 months
Secondary Cardiovascular events Incidence of cardiovascular events in patients after EVAR 30 days
Secondary Cardiovascular events Incidence of cardiovascular events in patients after EVAR 6 months
Secondary Cardiovascular events Incidence of cardiovascular events in patients after EVAR 12 months
Secondary Thromboembolic events Incidence of thromboembolic events in patients after EVAR 30 days
Secondary Thromboembolic events Incidence of thromboembolic events in patients after EVAR 6 months
Secondary Thromboembolic events Incidence of thromboembolic events in patients after EVAR 12 months
Secondary Complications of surgical procedure Incidence of Complications of surgical procedure 30 days
Secondary Complications of surgical procedure Incidence of Complications of surgical procedure 6 months
Secondary Complications of surgical procedure Incidence of Complications of surgical procedure 12 months
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