Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): A randomised, parallel-group, allocation concealed, controlled, open, phase 3 pragmatic clinical and cost- effectiveness trial with internal pilot - Alpha-2 agonists for sedation (A2B Trial)

niversity of Edinburgh and NHS Lothian0 个研究点目标入组 1,737 人开始时间: 2018年8月29日最近更新: 2019年4月30日

试验速览

暂无简介。

•1.Patient requiring 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 at the time of randomisation in the opinion of the responsible clinician
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 580
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1157

•1.Acute brain injury
•2.Post-cardiac arrest
•3.Status epilepticus
•4.Continuous therapeutic neuromuscular paralysis at the time of screening or randomisation
•5.Guillain-Barre Syndrome
•6.Myasthenia gravis1
•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.

发起方

niversity of Edinburgh and NHS Lothian