A2B
Alpha 2 agonists for sedation to produce better outcomes from critical illness: A randomised, parallel-group, allocation concealed, controlled, open, phase 3 pragmatic clinical and cost- effectiveness trial with internal pilot
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 we want to keep patients less sedated, but it is difficult to get the balance of sedation and comfort right. The purpose of this study is to compare if patients on dexmedetomidine or clonidine come off the ventilator quicker than those just on propofol. We will also see if there was a difference between the groups in the number of people who experienced delirium in ICU, compare how comfortable people were and measure if participants memories of being in ICU differed.
Chief Investigator: Professor Timothy Walsh
Number and location of participating sites / geographical scope (by region/ country): UK – 40-50 sites
EudraCT number: 2018-001650-98
Funder: NIHR Health Technology Assessment (HTA) Programme. Ref : HTA 16/93/01
Start and End date
Of grant award: April 2018 - September 2023
Of recruitment: Grant start date: July 2018 - October 2022
Current Status: in recruitment
Study Protocol:
Patient Information Sheets:
Co-enrolment between A2B and the following non-CTIMP studies has been agreed: ADAPT-Sepsis; A-STOP; BLING III, The Norepinephrine Response Test (NRT) study; REST; FLO-ELA; EFFORT; RADAR-2; GAinS; Cryostat-2, SARIPOC, HOT-ICU, INHALE, ABC Post-ICU, RECOVERY-RS, UK-ROX, MERIT
Co-enrolment between A2B and the following observational/sampling studies has been agreed: Appetite; Genomic; Iona; EPICS; ILTIS, Sepsis Immunomics, PARIS, Aspi-Flu, Phind, MOSES, ARDS-Neut, PQIP, CIRCA, KRAKIL, VAMp-Sepsis, Gut-Liver Axis (GLA), ISARIC, PREFIBRILLATE, PIMMS, CandiRes, ENLIST, NOVEL
Sponsor: The University of Edinburgh and Lothian Health Board, ACCORD (ref: AC18022),The Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ. http://accord.scot/
Chief Investigator: Professor Timothy Walsh Timothy.Walsh@ed.ac.uk
Trial Manager: Julia Boyd, Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Level 2, Nine Edinburgh BioQuarter, 9 Little France Rd, Edinburgh EH16 4UX Julia.Boyd@ed.ac.uk
ECTU Involvement: Trial management /Statistics/ Database and randomisation service.
(UKCRC)