EUCTR2021-005876-21-DK进行中（未招募）1 期
The Danish Out-of-Hospital Cardiac Arrest study (DANOHCA) - The DANOHCA study
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet0 个研究点目标入组 1,000 人开始时间: 2021年12月20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
- 1,000
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. Age =18 years
- •2. OHCA of presumed cardiac cause
- •3. Sustained ROSC#
- •4. Unconsciousness (GCS <9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization
- •# Sustained ROSC: Sustained ROSC is when chest compressions or mechanical circulatory support have been not required for 20 consecutive minutes and signs of circulation persist.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
排除标准
- •1. Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window)
- •2. Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
- •3. Suspected or confirmed acute intracranial bleeding
- •4. Suspected or confirmed acute stroke
- •5. Unwitnessed asystole
- •6. Known limitations in therapy and Do Not Resuscitate-order
- •7. Known disease making 180 days survival unlikely
- •8. Known pre-arrest CPC 3 or 4 functional status
- •9. >3 hours (180 minutes) from ROSC to screening
- •10. Systolic blood pressure <80 mm Hg despite fluid loading/vasopressor and/or inotropic medication#
- •11. Use of intra-aortic balloon pump/axial flow device/ECMO†
- •12. Temperature on admission <30°C
- •Further exclusion criteria specific to the trial interventions:
- •13. Known allergy from dexamethasone or olanzapine
- •14. Ongoing (within 48 h) treatment with dexamethasone or olanzapine
- •15. Known back or hip condition that precluded the patients from being positioned with backrest from 0 to 45-degree angle
- •16. Known or suspected Long QT Syndrome (LQTS)
- •17. Known active fungal disease. Localized skin lesions do not exclude patients from inclusion
- •18. Estimated body weight <45kg
- •# If the systolic blood pressure (SBP) is recovering during the inclusion window (180 minutes) the patient may be included
- •† If the patient is weaned and the device is removed during the inclusion window (180 minutes) the patient may be included
研究者
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