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Effect of Dexamethason on Postimplantation Syndrome After EVAR

NCT06044480 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2023-09-21

No results posted yet for this study

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

Interventions

DRUG

Dexamethasone

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

OTHER

Placebo

Administration of the same amount of saline solution instead of dexamethasone

Sponsors & Collaborators

  • Centro Hospitalar de Lisboa Central

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06044480 on ClinicalTrials.gov