Effect of Dexamethason on Postimplantation Syndrome After EVAR

NCT06044480 | Not Yet Recruiting Phase 4

• 1 other identifier: CHULC.CI.110.2020
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multi center double-blinded randomized controlled superiority trial, comparing the effects on postimplantatrion syndrome of a single preoperative dose of dexamethasone vs. standard treatment in endovascular aneurysm repair. Participating researchers must be vascular surgeons or vascular anesthesiologists certified by national entities. Recruitment is expected to begin in the second semester of 2023. The trial will follow the ICH-GCP guidelines and national and international legislation and reporting will be performed according to CONSORT 2010 guidelines. Site inclusion requires hospital ethics committee approval. Written informed consent is mandatory for all patients and the information and consent forms must be approved by Institutional Ethics Committee.

Conditions

Aneurysm Abdominal; Endovascular Aneurysm Repair; Postimplantation Syndrome; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Postimplantation syndrome incidence

  Occurrence of postimplantation syndrome, which is defined as fever (auricular temperature \>38ºC) and elevation of CRP (\> 75 mg/L), during the first 3 days after operation.

  3 days after surgery

Secondary Outcomes (5)

• Length of hospital stay (days)

  1 year

• cardiovascular events

  1 year

• Rate of AAA-related complications

  1 year

• Quality of life (EQ-5D)

  1 year

• Safety outcomes

  30 days after surgery

Study Arms (2)

dexamethasone

ACTIVE COMPARATOR

This group of participans will be submitted to a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation.

Drug: Dexamethasone

placebo

PLACEBO COMPARATOR

This group of patients will be submitted to a same amount of saline solution.

Other: Placebo

Interventions

Dexamethasone DRUG

Administration of a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation.

dexamethasone

Placebo OTHER

Administration of the same amount of saline solution instead of dexamethasone

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective treatment for a degenerative infrarenal abdominal aortic aneurysm by implantation of an endograft
• Additional procedures, as endoanchors, proximal extension with a cuff or iliac branch device, during primary EVAR are allowed.

You may not qualify if:

• Mycotic aneurysms, aortic dissections and inflammatory aneurysms
• Known inflammatory or infectious diseases
• Preoperative anti-inflammatory therapeutic

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Rita Ferreira, MD

CONTACT

+351213594000; rita.sferreira33@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: September 21, 2023
• Study Start: November 1, 2023
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share