Alpha 2 Agonists for Sedation to Produce Better Outcomes From Critical Illness (A2B Trial)

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Many patients in intensive care (ICU) need help to breathe on a breathing machine and need pain killers and sedatives to keep them comfortable and pain free. However, keeping patients too deeply sedated can make their ICU stay longer, can cause ICU confusion (delirium) and afterwards may cause distressing memories. Ideally patients should be kept less sedated, but it is difficult to get the balance of sedation and comfort right.

The investigators want to know whether starting an alpha2-agonist drug early in ICU can help keep patients more lightly sedated but still comfortable, and whether patients spend less time on the ventilator. The investigators also want to know how safe they are and if they can improve important outcomes during ICU stay and during recovery. The investigators also want to know if they are value for money.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Edinburgh
• Collaborators: Edinburgh Napier University; Imperial College London; King's College London; NHS Lothian; Queen's University, Belfast; Royal Surrey County Hospital NHS Foundation Trust; The University of Queensland; University College, London; University Hospital of Wales; University of Cambridge; University of Manchester; University of Warwick; West Hertfordshire Hospitals NHS Trust
• Treatments: Adrenergic alpha-2 Receptor Agonists; Clonidine; Dexmedetomidine; Propofol

Criteria

Inclusion Criteria:

1. Patient requiring mechanical ventilation (MV) in an ICU

2. Aged 18 or over

3. Within 48 hours of first episode of mechanical ventilation 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

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

18. Patient known to have experienced a period with heart rate <50 beats per minute for 60 minutes or longer since commencing mechanical ventilation in the ICU