High Dose Steroids for Liver Resection - Effect on Complications and Endothelial Function in the Immediate Postoperative Phase - a Randomized, Doubleblind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Complications, Post-anesthesia Care Unit (PACU)
研究概览
简要总结
Background:
Several randomized clinical trials have shown beneficial effects of pre-operative glucocorticoids on post-operative complications.
Studies on the effects of glucocorticoids on the postoperative recovery after liver-resection show significantly lower markers of infection and liver damage, and some studies have shown a shorter hospital stay.
Studies on the effects in the immediate postoperative phase are lacking.
Methods: Randomized, double-blind, controlled trial evaluating incidence of postoperative complications in the immediate postoperative phase (and during admission) after open liver surgery. Participants are randomized to either active treatment (methylprednisolone 10 mg/kg) or control (8 mg dexamethasone), administered just prior to surgery.
All patients undergoing open liver resection at our institution are eligible. Included patients are stratified according to extent of surgery into minor (<3 segments) or major (≥3 segments) group.
Patients in major group participate in Substudy I (markers of endothelial damage).
Patients operated between January and July 2018 participate in Substudy II (delirium).
详细描述
Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.
The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.
Glucocorticoids (GC) can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence. Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.
Studies on pre-operative glucocorticoids before liver surgery have shown beneficial effects in regards to markers of liver damage and infection, but studies on clinical outcomes in the immediate post-operative phase are lacking.
The primary aim of this study is to investigate whether high dose pre-operative glucocorticoids reduce complications in the immediate post-operative course.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age minimum 18
- •Planned open liver resection (with or without combined ablation and/or
- •cholecystectomy)
- •Able to participate (self report pain/nausea)
- •Understands danish/english, or has an interpreter during admission
- •Signed consent form
排除标准
- •ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) procedure
- •Combined ventral herniotomy with implantation of mesh
- •Combined with operation on tumor in other organs
- •Insulin dependent diabetes
- •Current (<10 days) treatment with systemic glucocorticoids and/or immunosuppressive treatment (not including inhalations)
- •Epidural anesthesia not feasible
- •Pregnancy/breastfeeding
- •Allergy toward study medication
- •Inoperability
研究组 & 干预措施
Methylprednisolone
10 mg/kg, single preoperative infusion
干预措施: Methylprednisolone (Drug)
Dexamethasone
8 mg dexamethasone, single preoperative infusion
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Complications, Post-anesthesia Care Unit (PACU)
时间窗: up to 24 hours
Number of patients with any complication at any time, during stay in the PACU. Complications according to DASAIMS discharge criteria (modified Aldrete criteria)
Substudy I: Markers of Endothelial Dysfunction
时间窗: post-operative days 0 to 3
Amount of endothelial markers (Syndecan-1, soluble thrombomodulin, SE-Selectin, vascular endothelial growth factor (VEGF) )
Substudy II: Delirium
时间窗: 5 days
Number of patients with post-operative cognitive impairment, according to 3-minute diagnostic confusion assessment method (3D-CAM)
次要结局
- PACU Stay(up to 24 hours)
- Nausea(up to five days)
- Analgesic Requirements(up to five days)
- Mortality(30 days)
- Total Complication Rate(30 days)
- ALAT(up to five days)
- Bilirubin(up to five days)
- INR(up to five days)
- Hospital Stay(3 months)
- Pain at Movement(up to 24 hours)
- Pain, Abdominal (Postoperative)(up to five days)
- Antiemetic Requirements(up to five days)
研究者
Kristin Julia Steinthorsdottir
Principal Investigator
Rigshospitalet, Denmark