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

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.

Conditions

• Critical Illness

Interventions

DRUG

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.

DRUG

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.

DRUG

Propofol

Patients will continue to receive intravenous propofol according to current usual care.

Sponsors & Collaborators

• West Hertfordshire Hospitals NHS Trust

  collaborator OTHER

• Queen's University, Belfast

  collaborator OTHER

• The University of Queensland

  collaborator OTHER

• University Hospital of Wales

  collaborator OTHER

• Edinburgh Napier University

  collaborator OTHER

• King's College London

  collaborator OTHER

• University of Warwick

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• Royal Surrey County Hospital NHS Foundation Trust

  collaborator OTHER

• University College, London

  collaborator OTHER

• NHS Lothian

  collaborator OTHER_GOV

• Imperial College London

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• University of Edinburgh

  lead OTHER

Principal Investigators

• Timothy Walsh, MBChB MD MSc · University of Edinburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-10

Primary Completion

2023-12-14

Completion

2024-07-31

Countries

• United Kingdom

Study Locations