None listed
Conditions
Brief summary
Critically ill patients in the Intensive Care Unit (ICU) frequently develop delirium. Delirium is extremely distressing to patients and is associated with poor outcomes. There are two forms of delirium, hyperactive and hypoactive (or a mix of both). The hyperactive form is particularly dangerous as patients may become aggressive and remove interventions that are essential for survival and/or injure themselves or staff. Given the urgency with which to treat hyperactive delirium, health care workers frequently administer potent antipsychotic medications to control delirium symptoms. However, we do not know if this is beneficial or harmful or if one antipsychotic medication is a better choice over the other. The purpose of this study is to compare the safety and efficacy (effectiveness) of the two most frequently prescribed antipsychotic medications (quetiapine and olanzapine) for hyperactive (agitated) delirium in critically ill patients.
Interventions
This multicentre, cluster randomised, double cross over, pragmatic clinical trial will compare the safety and efficacy of enteral (tablet) olanzapine with quetiapine in critically ill patients with hyperactive delirium. The double cross over design means that we will randomise ICUs (instead of individual patients) to the open label use of olanzapine or quetiapine over four treatment periods, with each treatment period being a three-month block. Dosage of anti-psychotic (using allocated anti-psyc
This multicentre, cluster randomised, double cross over, pragmatic clinical trial will compare the safety and efficacy of enteral (tablet) olanzapine with quetiapine in critically ill patients with hyperactive delirium. The double cross over design means that we will randomise ICUs (instead of individual patients) to the open label use of olanzapine or quetiapine over four treatment periods, with each treatment period being a three-month block. Dosage of anti-psychotic (using allocated anti-psychotic for that treatment period) will be left to discretion of treating clinician. Usual daily doses of olanzapine would be 20mg or less (in divided doses). Usual daily doses of quetiapine would be 200mg or less (in divided doses). Medication charts are reviewed daily. The plan for study drug administration is that the patient exclusively receives the allocated enteral anti-psychotic for the first three doses of pharmacological hyperactive delirium treatment (including doses administered as part of the regular regime or when required) before other agents are considered as part of hyperactive delirium ‘usual care’ (with the exception of the alternative anti-psychotic i.e. no use of olanzapine if the ICU is currently randomised to the quetiapine arm). Usual care is in accordance with (the ICU section of) hospital delirium guidelines where quetiapine and olanzapine are potential therapies. Duration of study treatment will be until death, discharge from ICU, 14 days after commencing treatment, or the treating Intensivist believes the patient no longer requires the use of an anti-psychotic to treat hyperactive delirium, whichever comes first. If clinicians deem the study drug (olanzapine or quetiapine) should continue after ICU, this is allowed according to clinical judgement. There will be no ‘washout’ between the crossover periods, but patients who remain in ICU at a point of crossover will remain on the treatment they were originally assigned.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed