Clinical Research Directory

Steroid Treatment to Prevent Thoracic Endovascular Aortic Repair Postimplantation Syndrome

Postimplantation syndrome (PIS) is a common and clinically important complication following thoracic endovascular aortic repair (TEVAR). PIS is characterized by a strong systemic inflammatory response to the stent-graft implantation and is manifested by flu-like symptoms, which include fever, increased white blood count, increased levels of acute phase proteins, and fatigue, but without a clear inflammatory and infective cause. Besides, it has been demonstrated that PIS is associated with prolonged hospital stay and increased risk for postoperative complications, including acute kidney injury, postoperative delirium, and increased postoperative pain scores. Recently, there has been increasing evidence that PIS is associated with an increased risk of major adverse cardiac events (MACE) and perioperative myocardial injury. Observational studies suggest that preoperative administration of glucocorticoids may decrease the incidence of PIS after TEVAR and EVAR procedures. However, to date, there are no randomised trials that have investigated whether preoperative administration of glucocorticoids can reduce the incidence of PIS and its associated poorer treatment outcomes following TEVAR. This randomized controlled trial was designed to investigate the effect of glucocorticoid administration on reducing the incidence and improving the outcome of patients who develop PIS after TEVAR.

Effect of Dexamethason on Postimplantation Syndrome After EVAR

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.