DRKS00020240已完成3 期
se of AnaConDa-50ml versus AnaConDa-100ml for sedation of invasively ventilated patients: an a-priori hypothesis substudy of a randomized controlled trial - ISOCONDA – small versus large
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •All patients treated with AnaConDa-50ml or with AnaConDa-100 ml in the Isoconda study.
- •Inclusion criteria for the main study called A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system
- •1. Male or female subjects, = 18 years (18 or older)
- •2. Continuous invasive ventilation and sedation = 48 hours (48 hours or less) at start of study sedation
- •3. Clinically likely to need invasive ventilation and sedation = 24 hours (24 hours or more) at randomisation
- •4. Ongoing sedation with propofol at time of randomisation
- •5. Prescribed target sedation depth within the RASS range -1 to -4
- •6. Signed informed consent or emergency situation inclusion criteria fulfilled and documented.
排除标准
- •Exclusion criteria for the main study called A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system
- •1. Has not reached prescribed target sedation depth any time within the last 8 hours at randomisation
- •2. History of or genetic predisposal for malignant hyperthermia
- •3. Uncompensated acute circulatory failure at time of randomisation (MAP < 55 mmHg despite iv fluids and vasopressors).
- •4. Hepatic impairment of classification C according to the Child-Pugh score (Cholongitas et al., 2005).
- •5. Any for the study, relevant clinically significant abnormalities in clinical chemistry or haematology results at the time of screening, precluding study participation, as judged by the investigator
- •6. Acute neuropathology without ICP monitoring, including but not limited to stroke, neurosurgery and head trauma.
- •7. Planned anaesthesia or surgery within 24 hours from randomisation
- •8. Tidal volume < 350 ml
- •9. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
- •10. Need for continuous muscle relaxation at the time of randomisation
- •11. Positive pregnancy test in women
- •12. History of allergy/hypersensitivity to isoflurane or propofol
- •13. Known participation in any other clinical study that included drug treatment within three months of the first administration of investigational product
- •14. Documented limitation of medical treatment.
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