Effect of Dexamethason on Postimplantation Syndrome After EVAR (DEPOS)

The Effect of Preoperative Dexamethasone on Postimplantation Syndrome After Endovascular Aneurysm Repair - Protocol for a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dexamethasone; Aneurysm Abdominal; Endovascular Aneurysm Repair; Postimplantation Syndrome
• Intervention / Treatment: Drug: Dexamethasone; Other: Placebo

Detailed Description

Post-Implantation Syndrome (PIS) consists on an inflammatory reaction after endovascular aneurysm repair of abdominal aortic aneurysms (EVAR) whose etiology and pathophysiology is still unclear, but is characterized by flu-like symptoms, with fever and elevation of analytical inflammatory parameters in the postoperative period. It is associated with a length of hospital stay and there are some studies that indicate an association with lower quality of life, increase in cardiovascular complications up to one year later and aneurysm-related complications.

PIS is defined by the presence of two criteria: tympanic temperature greater than 38ºC and CRP greater than 75 mg/L in the first three postoperative days.

Dexamethasone was the selected glucocorticoid, since it has virtually no action mineralocorticoid, has been tested in the perioperative context and is administered frequently in this context, namely at CHULC. Its use is intended to reduce symptoms associated with orotracheal extubation, pain, nausea and quality of life, without adverse effects relevant associates.

Study hypothesis: A single dose of 4mg dose of intravenous dexamethasone administered 30 minutes before surgery reduces the incidence and magnitude of PIS after EVAR.

Elegibility criteria: All the patients treated electively for a degenerative infrarenal abdominal aortic aneurysm by implantation of an endograft are eligible for this study. Patients treated for mycotic aneurysms, aortic dissections and inflammatory aneurysms are not eligible for this study, as well as patients with known inflammatory or infectious diseases and/or preoperative anti-inflammatory therapeutic.

If additional procedures, as endoanchors, proximal extension with a cuff or iliac branch device, are performed during primary EVAR, the patients should be enrolled.

Primary endpoints: The chosen primary endpoint is the 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.

Secondary endpoints Efficacy endpoints are length of hospital stay, cardiovascular events, AAA-related complications and quality of life at 30 days and one year.

Safety endpoints relate to potential side effects of dexamethasone, as taste disturbances, hyperglycemia, flushing, rise in blood pressure, palpitations, headache, sleep isturbances,depression,euphoria, bradycardia, and cardiac decompensation in the first 30 days after operation.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rita Ferreira, MD; Phone Number: +351213594000; Email: rita.sferreira33@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dexamethasone; 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; Administration of a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation.
Placebo Comparator: placebo; This group of patients will be submitted to a same amount of saline solution.	Other: Placebo; Administration of the same amount of saline solution instead of dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay (days)	Efficacy outcome	1 year
cardiovascular events	Efficacy outcome	1 year
Rate of AAA-related complications	Efficacy outcome	1 year
Quality of life (EQ-5D)	Efficacy outcome	1 year
Safety outcomes	Rate of side effects of dexamethasone	30 days after surgery

Collaborators and Investigators

• Sponsor: Centro Hospitalar de Lisboa Central

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Aortic Diseases; Aortic Aneurysm; Syndrome; Aneurysm; Aortic Aneurysm, Abdominal; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: CHULC.CI.110.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No