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Trial registered on ANZCTR
Registration number
ACTRN12624001075572
Ethics application status
Approved
Date submitted
16/08/2024
Date registered
5/09/2024
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A single centre pilot randomised controlled trial of enteral Guanfacine vs Quetiapine for agitated delirium in patients in the intensive care unit
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Scientific title
A single centre pilot randomised controlled trial of enteral Guanfacine vs Quetiapine for agitated delirium in patients in the intensive care unit
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Secondary ID [1]
312054
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Agitated delirium
333663
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Condition category
Condition code
Neurological
330352
330352
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients allocated to the intervention group will receive guanfacine for the treatment of agitated delirium. Guanfacine hydrochloride will be a single 2 mg dose given once a day via the oral route at the discretion of the treating ICU doctor for a maximum of 7 days while the patient is in ICU. From enrolment until day 8, treating ICU doctors will be permitted to use medication other than quetiapine for the treatment of delirium/agitation should it become necessary. On day 8 and onwards, the choice of anti-psychotic drug/agent will be at the discretion of the treating ICU doctors. Adherence will be monitored by review of medical records. All other aspects of care will conform to usual ICU practice. Blood pressure, heart rate will be monitored continuously and heart-rate corrected QT interval will be monitored as per usual routine care in intensive care unit. Usual practice in the intensive care unit of this study is for the treating medical team to prescribe medicines for the management of agitated delirium at their discretion and with the choice, dose and frequency also at their discretion.
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Intervention code [1]
328499
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Treatment: Drugs
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Comparator / control treatment
Patients in the control group will receive quetiapine as the primary care for treatment of agitation. Quetiapine will be started at a dose of 25 - 50 mg given once daily via enteral route. The dose will be titrated to efficacy and safety which is a maximum dose of 100 mg/day. There will otherwise be no deviation from routine ICU management.
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Control group
Active
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Outcomes
Primary outcome [1]
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For the composite outcome, our definition of hours of alive and agitation/coma-free is the number of hours in the first 7 days after the patient was randomly assigned to receive the guanfacine or quetiapine during which the patient is alive without agitation and not in drug induced coma (i.e. with a Richmond Agitation and Sedation scale (RASS) score of -2 to zero).
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Assessment method [1]
338116
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RASS score ranging from -5 to +4 as evaluated by bedside ICU registered nurse.
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Timepoint [1]
338116
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RASS score is recorded six hourly and reported in the electronic medical record.
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Secondary outcome [1]
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Presence of agitated delirium
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Assessment method [1]
434571
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Defined by number of days which Richmond Agitation Sedation Scale (RASS) score +1 or above. RASS score ranges from -5 to +4 as evaluated by bedside ICU registered nurse.
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Timepoint [1]
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Recorded 6-hourly in the electronic medical record. Data will be recorded until 7 day or until the patient is discharged from ICU.
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Secondary outcome [2]
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Lowest mean arterial pressure (MAP)
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Assessment method [2]
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Millimetres of mercury (mmHg) as measured by intra-arterial catheter.
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Timepoint [2]
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As recorded hourly in the patient’s medical record until 7 days or patient discharge from ICU.
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Secondary outcome [3]
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Lowest systolic blood pressure (SBP)
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Assessment method [3]
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Millimetres of mercury (mmHg) as measured by intra-arterial catheter.
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Timepoint [3]
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As recorded hourly in the patient’s medical record until 7 days or patient discharge from ICU.
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Secondary outcome [4]
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Lowest diastolic blood pressure (DBP)
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Assessment method [4]
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Millimetres of mercury (mmHg) as measured by intra-arterial catheter.
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Timepoint [4]
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As recorded hourly in the patient’s medical record until 7 days or patient discharge from ICU.
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Secondary outcome [5]
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Exposure to opioid medication
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Assessment method [5]
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Number of patients who receive opioids, duration of opioid use (reported as number of days), median daily dose and median cumulative dose (reported in microgram as fentanyl equivalent).
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Timepoint [5]
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As recorded in the patient’s medical record until 7 days or patient discharge from ICU.
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Secondary outcome [6]
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Exposure to benzodiazepine medication
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Assessment method [6]
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Number of patients who receive benzodiazepine at least once, duration of opioid use (reported as number of day), median daily dose and median cumulative dose (reported in milligram as midazolam equivalent).
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Timepoint [6]
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As recorded in the patient’s medical record until 7 days or patient discharge from ICU.
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Secondary outcome [7]
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Exposure to propofol medication
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Assessment method [7]
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Number of patients who receive opioids at least once, duration of opioid use (reported as number of day), median daily dose and median cumulative dose.
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Timepoint [7]
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As recorded in the patient’s medical record until 7 days or patient discharge from ICU.
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Secondary outcome [8]
434578
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Any adverse drug event related to the administration of guanfacine, for example fatigue and abdominal pain.
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Assessment method [8]
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Medical record audit
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Timepoint [8]
434578
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As recorded in the patient’s medical record until 7 days or patient discharge from ICU.
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Secondary outcome [9]
434579
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Any adverse drug event related to the administration of quetiapine, for example fatigue and abdominal pain.
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Assessment method [9]
434579
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Medical record audit
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Timepoint [9]
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As recorded in the patient’s medical record and occurring from the time of first study drug administration until 7 days or patient discharge from ICU.
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Secondary outcome [10]
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ICU length of stay in days.
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Assessment method [10]
434580
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Medical record audit
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Timepoint [10]
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Upon discharge from ICU, hospital or death, whichever occur first.
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Secondary outcome [11]
434581
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Hospital length of stay in days
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Assessment method [11]
434581
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Medical record audit
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Timepoint [11]
434581
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Upon discharge from ICU, hospital or death, whichever occur first.
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Secondary outcome [12]
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ICU mortality censored at 28-days
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Assessment method [12]
434582
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Medical record audit
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Timepoint [12]
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Upon discharge from ICU, hospital or death, whichever occur first.
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Secondary outcome [13]
434583
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Hospital mortality censored at 28-days
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Assessment method [13]
434583
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Medical record audit
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Timepoint [13]
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Upon discharge from ICU, hospital or death, whichever occur first.
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Eligibility
Key inclusion criteria
Adults aged equal to or older than 18 years
Admitted to the intensive care unit
Richmond Agitation Sedation Scale (RASS) score range of +1 to +4 points (agitation)
Physician has a plan to prescribe antipsychotic agent for treat agitation or delirium
The treating physician believed that guanfacine or quetiapine are equally appropriate for such treatment
• Likely to remain in the ICU until the day after tomorrow
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Admitted with a primary neurologic condition or injury, for example ischemic stroke, intracranial hemorrhage, active seizure
History of hepatic encephalopathy or end-stage liver disease defined as a Childs-Pugh class B or worse.
Previous diagnosis of psychiatric disorder or history of substance abuse
Actively withdrawing from alcohol intoxication and delirium tremens
Antipsychotic agent uses in the 10 days prior to Intensive care unit admission
Current treatment with dexmedetomidine or clonidine
Current treatment with an agent the potential to affect guanfacine or quetiapine concentrations that include cytochrome P450 subtype 3A4 inducer (e.g. phenobarbital, phenytoin, carbamazepine, rifampin) and 3A4 inhibitors (e.g. ketoconazole, voriconazole, clarithromycin)
Known allergy to guanfacine or quetiapine
Any contraindication to guanfacine or quetiapine includes borderline unsupported blood pressure defined by systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 40 mmHg, heart rate less than 50 beats per minute, and baseline QTc interval greater than 500 milliseconds.
Renal impairment which defined by creatinine clearance less than 30 ml/min, calculate by Cockcroft-Gault equation
Suspected or confirmed pregnancy at time of assessment of eligibility
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated permuted block
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2024
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Actual
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Date of last participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26955
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
43027
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
316415
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Hospital
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Name [1]
316415
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Austin Health
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Address [1]
316415
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Country [1]
316415
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Australia
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Primary sponsor type
Hospital
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Name
Austin Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
318583
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None
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Name [1]
318583
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Address [1]
318583
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Country [1]
318583
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315211
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
315211
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
315211
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Australia
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Date submitted for ethics approval [1]
315211
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30/04/2024
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Approval date [1]
315211
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15/08/2024
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Ethics approval number [1]
315211
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HREC/108664/Austin-2024
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Summary
Brief summary
Delirium is one of the most common neurological problems among hospitalized patients, especially in the intensive care unit (ICU). The prevalence of delirium among hospitalized patients ranges from 9.6% to 94.8%. Delirium is a risk factor for increased hospital length of stay (LOS) and decreased chance of home discharge. Patients experiencing agitated delirium often have poorer outcomes. In response, we will perform a single centre pilot randomised controlled trial of enteral guanfacine vs quetiapine for agitated delirium in patients in the intensive care unit. A total of 36 eligible patients will be allocated, on a 1:1 basis to either guanfacine or quetiapine for a period of 7-days while in ICU. Our findings will provide insights into the safety, efficacy and feasibility of guanfacine administration to agitated ICU patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Rinaldo Bellomo
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Address
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
133990
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Australia
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Phone
133990
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+61 394965992
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Fax
133990
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Email
133990
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[email protected]
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Contact person for public queries
Name
133991
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Rinaldo Bellomo
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Address
133991
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
133991
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Australia
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Phone
133991
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+61 394965992
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Fax
133991
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Email
133991
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[email protected]
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Contact person for scientific queries
Name
133992
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Rinaldo Bellomo
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Address
133992
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Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
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Country
133992
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Australia
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Phone
133992
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+61 394965992
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Fax
133992
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Email
133992
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Ethics approval not sought for sharing of patient data
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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