The Effects of Preoperative High-dose Dexamethasone on Inflammatory Response and Recovery After Emergency Laparotomy, a Randomized, Double-blind, Placebo-controlled Clinical Trial - AHA STEROID TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- plasma C-reactive protein
研究概览
简要总结
The aim of this trial is to evaluate the effect of high-dose glucocorticoid on inflammatory response and recovery after emergency laparotomy in participants with intestinal obstruction and perforated viscus.
Primary outcome is the reduction of C-reactive protein on postoperative day 1. Secondary outcomes are organ specific complications in the post anaesthesia phase, endothel and inflammatory markers, fluid status, preload dependency, pain, lung function, nausea and mobilization during the first 5 days after surgery, .
The investigators hypothesize, that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy.
详细描述
Surgical trauma and accompanying inflammation results in increased capillary permeability leading to tissue edema. Since the vascular endothelium contributes to homeostasis, endothelial damage may increase the risk of cardiovascular and hemodynamic complications.
Pre-operative high-dose glucocorticoids provide reduction in the inflammatory response after surgery, effective pain relief in several major surgical procedures, as well as reducing fatigue, impairing endothelial dysfunction, potentially amend fluid extravasation, edema and dyscoagulation and vasodilation.
However, glucocorticoids have not been assessed in patients with peritonitis or intestinal obstruction, specifically, the impact on pain, fluid dynamics, respiratory as well as endothelial function and mobilization in both obstruction and perforation.
In this study, patients will be randomized to either high dose dexamethason (1 mg /kg) or placebo (0,9% NaCl), administered as a single dose preoperatively. The investigatoris hypothesize that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology:
- •Primary perforated viscus (perforated ulcer, small intestine or colon)
- •Primary intestinal obstruction ( small intestine or colon)
- •Provided verbal and written informed consent
- •Must speak and understand the Danish language
排除标准
- •Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases.
- •Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage
- •Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute surgery is defined as surgery planned within 48 hours.
- •Intestinal Ischemia
- •intraabdominal bleeding
- •Traumas, gynecological, urogenital and other vascular pathology, pregnant participants.
- •Dementia and/or cognitive dysfunction (diagnosed).
- •Participants not oriented in time, place and person
- •Insuline treatment for diabetes mellitus type I and II
- •Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids)
- •Allergies to trial medicine
研究组 & 干预措施
Intestinal obstruction, Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes
干预措施: Dexamethasone 1 mg/kg (Drug)
Intestinal obstruction, PLACEBO
Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes
干预措施: Physiologic saline (Drug)
Perforated viscus, Dexamethasone 1 mg/kg
Dexamethasone 1 mg/kg administered preoperatively as an i.v. infusion over 10-15 minutes
干预措施: Dexamethasone 1 mg/kg (Drug)
Perforated viscus, PLACEBO
Physiologic saline, administered preoperatively as an i.v. infusion over 10-15 minutes
干预措施: Physiologic saline (Drug)
结局指标
主要结局
plasma C-reactive protein
时间窗: 24* hours (*+/- 6 hours) after surgery.
次要结局
- changes in plasma C-reactive protein(Preoperatively, 6 hours postoperatively, as well as postoperative day 3 and 5)
研究者
Mirjana Cihoric
MD, Research fellow
Copenhagen University Hospital, Hvidovre