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Alpha 2 Agonists for Sedation to Produce Better Outcomes From Critical Illness (A2B Trial)
Sponsor: University of Edinburgh
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1404
Start Date
2018-12-11
Completion Date
2024-07-31
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Dexmedetomidine
Patients will commence intravenous infusion of open-label study drug according to a weight-based dose regimen as early as possible post-randomisation, and within a maximum of two hours. Bedside clinical staff will transition patients to achieve sedation with the allocated α2-agonist agent as quickly as clinically feasible and safe, to replicate the way these drugs would be used in routine practice. Additional opiate will be used for analgesia using clinical judgement. Once established, additional propofol will only be used when the maximum α2-agonist dose is reached or because cardiovascular or other side-effects limit dose escalation.
Clonidine
Patients will commence intravenous infusion of open-label study drug according to a weight-based dose regimen as early as possible post-randomisation, and within a maximum of two hours. Bedside clinical staff will transition patients to achieve sedation with the allocated α2-agonist agent as quickly as clinically feasible and safe, to replicate the way these drugs would be used in routine practice. Additional opiate will be used for analgesia using clinical judgement. Once established, additional propofol will only be used when the maximum α2-agonist dose is reached or because cardiovascular or other side-effects limit dose escalation.
Propofol
Patients will continue to receive intravenous propofol according to current usual care.
Locations (38)
Belfast Health & Social Care Trust
Belfast, United Kingdom
South Eastern Health and Social Trust
Belfast, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Cardiff and Vale University Health Board
Cardiff, United Kingdom
Countess of Chester Hospital NHS Foundation Trust
Chester, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, United Kingdom
NHS Dumfries and Galloway
Dumfries, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Medway NHS Foundation Trust
Gillingham, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Harrogate and District NHS Trust
Harrogate, United Kingdom
Wye Valley NHS Trust
Hereford, United Kingdom
The Queen Elizabeth Hospital Kings Lynn NHS Foundation Trust
Kings Lynn, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
University Hospitals of Leicester
Leicester, United Kingdom
Lewisham and Greenwich NHS Trust
Lewisham, United Kingdom
Aintree University Hospital Foundation Trust
Liverpool, United Kingdom
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool, United Kingdom
Guys and St Thomas NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Manchester University Foundation Trust
Manchester, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Aneurin Bevan University Health Board
Newport, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford University Hospitals NHS Foundation Trust.
Oxford, United Kingdom
Poole Hospitals NHS Foundation Trust
Poole, United Kingdom
University Hospital Southampton NHSFT
Southampton, United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, United Kingdom
West Hertfordshire Hospitals NHS Trust
Watford, United Kingdom