Predictors of 30-day Postoperative Outcome After Elective EVAR

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05647486
• Other study ID #: 30-day outcome, EVAR
• Status: Completed
• Start date: March 23, 2016
• Est. completion date: January 13, 2021

Study information

• Verified date: December 2022
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: January 13, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

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