drugset / Trial / NCT06044480

Effect of Dexamethason on Postimplantation Syndrome After EVAR

NCT06044480 ↗

Phase 4 Unknown 158 enrolled Centro Hospitalar de Lisboa Central
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2023-11-01
Primary completion
2025-05-31
Completion
2026-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 4 mg Intravenous