Predictors of 30-day Postoperative Outcome After Elective EVAR

Sponsor

University of Thessaly (Other)

Overall Status

Completed

CT.gov ID

NCT05647486

Collaborator

(none)

322

Enrollment

Location

57.7

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics

Condition or Disease	Intervention/Treatment	Phase
Postoperative Complications	Other: 30-day postoperative outcome

Detailed Description

The study included 322 consecutive AAA patients treated electively with EVAR from March 2016 to February 2019 at a tertiary referral center.

Early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. Any adverse event, such as major adverse cardiovascular events (MACE), post-implantation syndrome (PIS), acute kidney injury (AKI), and deaths of any cause were recorded.

Study Design

Study Type:

Observational

Actual Enrollment :

322 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Predictors of 30-day Postoperative Outcome After Elective Endovascular Abdominal Aortic Aneurysm Repair

Actual Study Start Date :

Mar 23, 2016

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Jan 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
EVAR Patients with AAA, treated electively by EVAR. The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed.	Other: 30-day postoperative outcome The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed

Arm

Intervention/Treatment

EVAR

Patients with AAA, treated electively by EVAR. The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed.

Other: 30-day postoperative outcome

The 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics were assessed

Outcome Measures

Primary Outcome Measures

Number of patients with major adverse cardiovascular events [30rd day post-operatively]
Number of participants with major adverse cardiovascular events
Number of patients with acute kidney injury [30rd day post-operatively]
Number of participants with acute kidney injury according to the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) criteria
Number of patients with post-implantation syndrome [30rd day post-operatively]
Number of participants with post-implantation syndrome SIRS, without any apparent sign of infection
Deaths of any cause [30rd day post-operatively]
Number of participants who died from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Only patients managed with EVAR using standard bifurcated devices in elective setting were included.

Exclusion Criteria:

Patients treated for ruptured, symptomatic, inflammatory or infectious AAA were excluded. Furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. Additional exclusion criteria were the presence of any trauma or surgery within two months before EVAR, any autoimmune or systemic inflammatory disease and any malignancy. Of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an EVAR until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Larissa	Larissa	Thessaly	Greece	41110

Sponsors and Collaborators

University of Thessaly

Investigators

Study Chair: Eleni Arnaoutoglou, Professor, University of Thessaly

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elena Arnaoutoglou, Professor of Anesthesiology, University of Thessaly

ClinicalTrials.gov Identifier:

NCT05647486

Other Study ID Numbers:

30-day outcome, EVAR

First Posted:

Dec 12, 2022

Last Update Posted:

Dec 12, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Postoperative Complications

Study Results

No Results Posted as of Dec 12, 2022