Organ Donation and Vasopressor Use: Effects of Hydrocortisone Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- dosage and time on norepinephrine treatment
研究概览
简要总结
Brain death patients who are selected for organ donation very often suffer from haemodynamic instability. To treat this, high amounts of vasoactive drugs(norepinephrine) may be needed to raise blood pressure. However,norepinephrine may have negative influence on several organs causing reduced blood flow ischemia. Our hypothesis is that hydrocortisone treatment may reduce the amount of vasoactive drugs needed to keep the blood pressure stable in patients selected for organ donation.
详细描述
When patients are treated in the ICU only as possible organ donators they will be assessed for eligibility for the study. Iv hydrocortisone or placebo will be administered every 6 hours. Several hormonal samples will be collected.
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, Investigator)
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
- •all have to be fulfilled
- •severe brain injury or subarachnoid hemorrhage which progrediates to brain death and patients are treated only as candidates for organ donation in the ICU
- •no other reasons for treatment than organ donation
- •informed consent from official representative
排除标准
- •age under 18
- •pregnancy
- •corticoid treatment before study entry
- •adrenal insufficiency
- •hypophyseal insufficiency
- •treatment with etomidate one week before study entry
- •participating in an other study
- •no informed consent
研究组 & 干预措施
1
hydrocortisone treatment 50mg iv x4
干预措施: hydrocortisone (Drug)
2
Placebo iv every 6 hours
干预措施: sodium chloride (Drug)
结局指标
主要结局
dosage and time on norepinephrine treatment
时间窗: in ICU
次要结局
- Hormone levels and number of organs donated(Hospital treatment)
研究者
Stepani Bendel
MD PhD
Kuopio University Hospital