A multicentre, cluster randomised, double cross over pragmatic clinical trial comparing the safety and efficacy of enteral olanzapine with quetiapine in critically ill patients with hyperactive delirium

Phase 2

• Conditions: critical illness; hyperactive delirium; Neurological - Other neurological disorders

• Registration Number: ACTRN12622001532796
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-12
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

A patient in one of the three participating ICU's will be eligible if they are 18 years of age or older and require pharmacological treatment for hyperactive delirium as indicated by administration of an anti-psychotic (during their initial ICU admission).

Exclusion Criteria

Patients will be excluded if they were regularly taking an anti-psychotic medication prior to hospital admission or they have an allergy to either olanzapine or quetiapine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alive delirium/coma free days.<br> <br>A patient will be regarded as delirium/coma free for that calendar day if:<br>- They are alive and discharged from ICU OR<br>- They are alive in the ICU with:<br> - the Richmond Agitation - Sedation Scale (RASS) score being -2 or greater all day AND<br> - the Confusion Assessment Method for the ICU (CAM-ICU) assessment found to be negative (each time the assessment has been completed that calendar day)<br><br>Please note:<br>- All ICU patients have a CAM-ICU/RASS score recorded at least twice a day as part of standard clinical care at participating sites<br>- 'Delirium free days' commence once the patient is NOT delirious again throughout the 14-day study period<br>- If clinicians deem the study drug (olanzapine or quetiapine) should continue after ICU, this is allowed according to clinician judgement.<br>- This data is obtained from the electronic medical record by trained staff.[Censored at 14 days after study enrolment.]