EUCTR2018-004852-39-FR进行中(未招募)1 期
Benefit of a flash dose of corticosteroids in digestive surgical oncology: a randomized, double blind, placebo-controlled trial
CHU Dijon Bourgogne0 个研究点目标入组 1,200 人开始时间: 2019年3月14日最近更新:
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
- 1,200
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
- •- Age = 18 years
- •- Undergoing elective surgery for a digestive cancer (except purely hepatic surgery)
- •- Patients operated in a curative intent
- •- Patients who had given their written informed consent
- •- Patients affiliated to a National health insurance scheme
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Emergency surgery
- •- Pregnant or breastfeeding women
- •- Patients with an ongoing oral treatment by steroids
- •- Palliative surgery
- •- Exclusive liver surgery
- •- Colorectal resection with concomitant hyperthermic intraperitoneal chemotherapy
- •- Patient with at least one contra-indication to methylprednisolone treatment :
- •* active infection
- •* on course viral disease (particularly hepatitis, herpes, chickenpox, herpes zoster
- •* uncontrolled psychotic state
- •* hypersensitivity to methylprednisolone or to one of its excipient
- •- ASA grade >3
- •- Persons subject to a measure of legal protection (guardianship, tutorship)
- •- Persons subject to a court order
- •- Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
研究者
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