Alpha-2 Agonists for sedation to produce better outcomes from critical illness (‘A2B Trial’)

Phase 1

• Conditions: Any patient requiring intensive care treatment due to critical illness.; MedDRA version: 20.1 Level: LLT Classification code 10033305 Term: Oversedation System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0 Level: PT Classification code 10039897 Term: Sedation System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0 Level: LLT Classification code 10049124 Term: Sedation during medical procedure System Organ Class: 100000004865; MedDRA version: 20.1 Level: LLT Classification code 10039898 Term: Sedation excessive System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-001650-98-GB
• Lead Sponsor: niversity of Edinburgh and NHS Lothian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-29
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1737

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified