ISRCTN18035454已完成3 期
Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): a randomised, parallel-group, allocation concealed, controlled, open, Phase III pragmatic clinical and cost-effectiveness trial with internal pilot
Academic and Clinical Central Office for Research and Development (ACCORD)0 个研究点目标入组 1,437 人开始时间: 2018年10月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,437
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38072483/ (added 30/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 22/06/2020:
- •1. Patient requiring mechanical ventilation (MV) in an ICU
- •2. Aged 18 years or over
- •3. Within 48 h of first episode of MV in ICU
- •4. Requiring sedation with propofol
- •5. Expected to require a total of 48 hours of MV or more in ICU
- •6. Expected to require a further 24 hours of MV or more at the time of randomisation in the opinion of the responsible clinician
- •Previous inclusion criteria:
- •1. Patient requiring mechanical ventilation (MV) in an ICU
- •2. Aged 18 or over
- •3. Within 48 hours of starting MV in an ICU
- •4. Requiring sedation with propofol
- •5. Expected to require a total of 48 hours of MV or more in ICU
- •6. Expected to require a further 24 hours of MV or more at the time of randomisation in the opinion of the responsible clinician
排除标准
- •Current exclusion criteria as of 22/06/2020:
- •1. Acute brain injury (traumatic brain injury; intracranial haemorrhage; ischaemic brain injury from stroke or hypoperfusion)
- •2. Post-cardiac arrest (where there is clinical concern about hypoxic brain injury)
- •3. Status epilepticus
- •4. Continuous therapeutic neuromuscular paralysis at the time of screening or randomisation
- •5. Guillain-Barre Syndrome
- •6. Myasthenia gravis
- •7. Home ventilation
- •8. Fulminant hepatic failure
- •9. Patient not expected to survive 24 h by responsible clinician
- •10. Decision to provide only palliative or end-of-life care
- •11. Pregnancy
- •12. Known allergy to one of the study drugs
- •13. Untreated second or third degree heart block
- •14. Transferred from another Intensive Care Unit in which MV occurred for >6 h
- •15. Prisoners
- •16. Enrolled on another CTIMP
- •17. Previously enrolled on the A2B Trial
- •18. Patients with bradycardia: a heart rate of <50 bpm for a period of 60 min or longer since starting MV in the ICU
- •Previous exclusion criteria:
- •1. Acute brain injury (traumatic brain injury; intracranial haemorrhage; ischaemic brain injury from stroke or hypoperfusion)
- •2. Post-cardiac arrest (where there is clinical concern about hypoxic brain injury)
- •3. Status epilepticus
- •4. Continuous therapeutic neuromuscular paralysis at the time of screening or randomisation
- •5. Guillain-Barre Syndrome
- •6. Myasthenia gravis
- •7. Home ventilation
- •8. Fulminant hepatic failure
- •9. Patient not expected to survive 24 hours by responsible clinician
- •10. Decision to provide only palliative or end-of-life care
- •11. Pregnancy
- •12. Known allergy to one of the study drugs
- •13. Untreated second or third degree heart block
- •14. Transferred from another Intensive Care Unit in which MV occurred for >6 hours
- •15. Prisoners
- •16. Enrolled on another CTIMP
- •17. Previously enrolled on the A2B Trial
研究者
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