The Effect of Preoperative Dexamethasone on Postimplantation Syndrome After Endovascular Aneurysm Repair - Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 主要终点
- Postimplantation syndrome incidence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
dexamethasone
This group of participans will be submitted to a single preoperative dose of 4 mg of dexamethasone given intravenously 30 minutes before operation.
干预措施: Dexamethasone (Drug)
placebo
This group of patients will be submitted to a same amount of saline solution.
干预措施: Placebo (Other)
结局指标
主要结局
Postimplantation syndrome incidence
时间窗: 3 days after surgery
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.
次要结局
- 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)