EUCTR2020-002586-34-DK进行中（未招募）1 期
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 TRIA
Department of Anesthesiology, Copenhagen University Hospital Hvidovre, Capital Region of Denmark0 个研究点目标入组 110 人开始时间: 2020年7月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology:
- •a.Primary perforated viscus (perforated ulcer, small intestine or colon)
- •b.Primary intestinal obstruction ( small intestine or colon)
- •2.Provided verbal and written informed consent
- •3.Must speak and understand the Danish language
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1.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.
- •2.Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage
- •3.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.
- •4.Intestinal Ischemia
- •5.intraabdominal bleeding
- •6.Traumas, gynecological, urogenital and other vascular pathology, pregnant participants.
- •7.Dementia and/or cognitive dysfunction (diagnosed).
- •8.Participants not oriented in time, place and person
- •9.Insuline treatment for diabetes mellitus type I and II
- •10.Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids)
- •11.Allergies to trial medicine
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