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Trial registered on ANZCTR
Registration number
ACTRN12625000103460p
Ethics application status
Submitted, not yet approved
Date submitted
10/01/2025
Date registered
30/01/2025
Date last updated
30/01/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Safety and feasibility of Intramuscular Dexmedetomidine for Delirium
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Scientific title
Safety and feasibility of IntraMuscular DEXmedetomidine in reducing the incidence of delirium in at risk Intensive Care Unit patients: a pilot randomised trial
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Secondary ID [1]
313679
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None
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Universal Trial Number (UTN)
U1111-1317-5395
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Trial acronym
SIMDEX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Delirium
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critical illness
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Condition category
Condition code
Neurological
332797
332797
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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
• A daily dose of 1 mcg/kg dexmedetomidine (max of 100 mcg).
• Given intramuscularly in the deltoid or gluteal muscle between 7 – 9 pm
• Administered while in the ICU for up to a maximum of five days
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Intervention code [1]
330272
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Treatment: Drugs
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Comparator / control treatment
• Usual clinician-dependent approach to the management of delirium risk.
• This may involve appropriate analgesic assessment and management, early mobility and exercise, family engagement, maximising sleep, preserving the day-night cycle where able.
• This may also involve the use or cessation of of sedative, neuroleptic or anaesthetic medication.
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Control group
Active
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Outcomes
Primary outcome [1]
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Significant Adverse Cardiovascular Event (ACE) (safety and Feasibility)
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Assessment method [1]
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One or more of the following: o Heart rate decrease to < 50 bpm on cardiac monitoring o Increase Noradrenaline requirements by >5 mcg/min or new vasopressor requirement from electronic medical records o Sustained drop in SBP to < 90 for > 5 minutes, requiring intervention or associated with symptoms on central monitoring of intra-arterial blood pressure o New Arrhythmia requiring intervention on cardiac monitoring
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Timepoint [1]
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48h post each intramuscular dexmedetomidine dose delivery
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Secondary outcome [1]
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Reasons for exclusions
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Assessment method [1]
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As per protocol, from audit of study enrolment, withdrawal and screening logs
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Timepoint [1]
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Cumulative exclusion data will be assessed at the conclusion of the study.
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Secondary outcome [2]
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Occurrence of delirium D1 post-IM DEXMED administration
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Assessment method [2]
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4AT Score and Mini Mental State Examination - If patients score > 23/30 on the MMSE then a 4AT Score will be performed - A 4AT Score greater than or equal to 4 will indicate delirium
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Timepoint [2]
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24h post administration of first intra-muscular dose
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Secondary outcome [3]
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Number and nature of adverse events in each group
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Assessment method [3]
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Development of the following conditions or events will be identified and labelled as an adverse event using the electronic medical record if they occur within 48h of intramuscular dexmedetomidine administration. • Development of Acute Kidney Injury • Development of polyuria (defined as unprovoked urine output >100ml/hr for more than 3h) • Development of heart block (Mobitz II or 3rd degree) • Development of fever unrelated to concomitant infection • Seizures or acute neurological signs • Cardiac arrest • Coma • Hypotension • Heart rate decrease to < 50 bpm • Increase Noradrenaline requirements by >5 mcg/min or new vasopressor requirement • Sustained drop in SBP to < 90 for > 5 minutes, requiring intervention or associated with symptoms • New Arrhythmia requiring intervention • Rhabdomyolysis, defined as significant myoglobinura or a CK > 1000/5000
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Timepoint [3]
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Unitl 48h after the administration of an intramuscular treatment dose of dexmedetomidine
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Secondary outcome [4]
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Randomised to screened patient ratio
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Assessment method [4]
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Patients randomised/Patients screened from audit of study enrolment, withdrawal and screening logs
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Timepoint [4]
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Post-study completion
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Secondary outcome [5]
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Sleep efficiency
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Assessment method [5]
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% of sleep time Actigraphy using the GENEActiv Original activity monitor device
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Timepoint [5]
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Measured overnight until waking, Night 1, 2, 3 from initial randomisation.
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Secondary outcome [6]
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Incidence of physical restraint use
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Assessment method [6]
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Hours per day as per recorded in EMR
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Timepoint [6]
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Daily totals until ICU discharge.
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Secondary outcome [7]
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Pharmacokinetics of Dexmedetomidine
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Assessment method [7]
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Plasma levels of dexmedetomidine concentrations
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Timepoint [7]
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1h, 4h, 9-12h post-administration each intra-muscular dose (last to coincide with routine blood tests)
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Secondary outcome [8]
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Number of days alive and delirium free days to 14 days (this is a composite outcome)
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Assessment method [8]
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4AT Score and Mini Mental State Examination - If patients score > 23/30 on the MMSE then a 4AT Score will be performed - A 4AT Score greater than or equal to 4 will indicate delirium
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Timepoint [8]
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Daily until D14 post-randomisation
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Secondary outcome [9]
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Incidence and intensity of pharmacological therapy for delirium
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Assessment method [9]
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Composite outcome consisting of the receipt (yes or no) and dose (mg/kg and mg) of the neuroleptic agents, as per EMR prescription record o Olanzapine o Quetiapine o Benzodiazepines o Haloperidol
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Timepoint [9]
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Daily totals until ICU discharge.
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Secondary outcome [10]
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Sleep architecture (% time awake, in REM, in Stage N1/2/3 Sleep)
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Assessment method [10]
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The X8 Sleep Profiler Real Time Acquisition System (BMedical P/L) using a proprietary algorithm based on: o Electroencephalographic (EEG) o Electromyographic (EMG) o Electrooculographic (EOG) o Electrocardiographic (ECG) signals o Photoplethysmographic (PPG) signal o Sound, movement, and position.
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Timepoint [10]
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Measured overnight until waking, Night 1, 2, 3 from initial randomisation.
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Secondary outcome [11]
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Compliance with drug administration protocol
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Assessment method [11]
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Number and type of daily protocol violations, as per trial protocol, from audit of study protocol violation logs.
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Timepoint [11]
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Daily totals on days intramuscular dexmedetomidine is administered.
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Eligibility
Key inclusion criteria
Patients must satisfy ALL of the following inclusion criteria:
1. Aged 65 or older on the day of screening.
2. Expected to stay in ICU for longer than 24 hours.
3. Not receiving invasive mechanical ventilation
4. Arterial line in situ prior to the first dose of the drug to enable blood sampling
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Minimum age
65
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
Exclusion Criteria
Patients must not have ANY of the following exclusion criteria:
1. Any contraindication or allergy to dexmedetomidine
2. Patients admitted with any form of acute neurological disturbance
a. Suspected or proven acute primary brain injury
b. Acute encephalopathy or altered level of consciousness
c. Patients receiving therapy for delirium or agitation
d. Documented history of cognitive decline or dementia
e. Chronically receiving multiple antipsychotic medications
3. Haemodynamic Concerns, defined as:
a. Requiring significant vasopressor support
i. Norepinephrine > 0.2 mcg/kg/min or equivalent
b. Heart rate <50/min in the absence of a functioning pacemaker
c. Systolic blood pressure of < 100 mmHg with or without pressor support
4. Significant coagulopathy defined by either of:
a. Platelets of < 50,000
b. INR > 3
5. Acute fulminant hepatic failure
6. Pregnancy or active breastfeeding
7. Incipient mortality, or moribund patient likely to die within the next 48h
8. Undergoing active palliative care intervention at the end of life
9. Unable to receive intramuscular injections for any reason
10. Enrolled in other trials of dexmedetomidine
11. Previously enrolled in this study
12. Any other relevant significant clinical reason identified by the treating team
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Study design
Purpose of the study
Prevention
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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)
A permuted block randomisation with stratification by study site, age (65-75, 75-85, >85), the presence or absence of frailty (Clinical Frailty Score >4) and admitting diagnosis (surgical vs medical) will be used.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety
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Statistical methods / analysis
Summary statistics will be used to describe the clinical data and presented as mean ± SD, median with interquartile range or percentages as appropriate. Chi-squared analysis (with Fisher’s exact test if appropriate), Student’s t-test or the Mann Whitney U test, or linear regression will be used to compare data between the intervention and usual care groups. Statistical significance declared for probability values of < 0.05. There will be no imputation for missing data.
Qualitative and quantitative analyses will be performed to assess the primary outcome of feasibility. Variable Free Day outcomes will be undertaken as time-to-event analyses using a competing risks regression framework, with death as a competing event. If no deaths are observed, then analysis will revert to Cox proportional hazards regression. The group estimates will be presented as the respective sub-hazard (or hazard) ratios with associated 95% confidence intervals (95%CI), and presented as the respective cumulative incidence rates as per Fine & Gray. A secondary analysis will be adjusted for age and frailty. Length of ICU stay will be analysed similarly as days alive and ICU-free at day 14, with deaths assigned zero.
Pre-specified subgroup analyses will include age (65-75, 75-85, >85); frailty (CFS <4 or = 4); sepsis (yes/no); surgical admission (yes/no); severity of illness (APACHE II < 25 vs. = 25). The analyses for the heterogeneity of effects across subgroups will use a treatment × subgroup interaction term added to the logistic regression described above.
Baseline covariates will be presented as number (%), median [interquartile range, IQR], or mean (standard deviation, SD); between group differences will be analysed by chi-squared, Kruskal-Wallis test or linear regression.
Plasma concentration-time curves for dexmedetomidine will be presented as mean profiles with corresponding 95%CI.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
7/04/2025
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Actual
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Date of last participant enrolment
Anticipated
6/04/2026
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Actual
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Date of last data collection
Anticipated
31/05/2026
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Actual
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Sample size
Target
60
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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]
27459
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [2]
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Dandenong Hospital- Monash Health - Dandenong
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Recruitment hospital [3]
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Casey Hospital - Berwick
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Recruitment hospital [4]
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Victorian Heart Hospital - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3175 - Dandenong
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Recruitment postcode(s) [3]
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3806 - Berwick
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Intensive Care Unit Institutional Funding, Monash Health
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Address [1]
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Country [1]
318142
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Australia
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Primary sponsor type
Hospital
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Name
Monash Health
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320588
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Country [1]
320588
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
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https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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05/09/2024
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Approval date [1]
316788
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Ethics approval number [1]
316788
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Summary
Brief summary
This is a pilot feasibility randomized clinical trial comparing the novel intramuscular use of dexmedetomidine, an alpha-2 agonist agent, in preventing delirium and improving sleep in older, non-ventilated intensive care patients, compared with usual care. The main aims are to determine if using the drug in this context is safe, and if further, larger studies would be feasible.
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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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Dr Adrian Pakavakis
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Address
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Department of Intensive Care, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168
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Country
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Australia
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Phone
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+61 03 9594 3277
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Fax
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Email
139014
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[email protected]
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Contact person for public queries
Name
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Ms Alice Li
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Address
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Department of Intensive Care, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168
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Country
139015
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Australia
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Phone
139015
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+61 03 9594 3196
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Fax
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Email
139015
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Neil Glassford
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Address
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Department of Intensive Care, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168
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Country
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Australia
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Phone
139016
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+61 03 9594 3277
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Fax
139016
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Email
139016
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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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