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Trial registered on ANZCTR


Registration number
ACTRN12611000166976
Ethics application status
Not yet submitted
Date submitted
18/01/2011
Date registered
11/02/2011
Date last updated
11/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Sedation Practice in Intensive Care in Australia and New Zealand- A Pilot Study
Scientific title
A randomised controlled trial of a sedative regimen that utilises dexmedetomidine as the primary agent and minimises the use of midazolam compared with current sedation practice in intensive care patients on outcomes of mortality, cognitive function and Health Related Quality of Life.
Secondary ID [1] 253435 0
Nil
Universal Trial Number (UTN)
U1111-1119-1020
Trial acronym
SPICE Pilot.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedation in intensive care patients 260980 0
Condition category
Condition code
Other 259116 259116 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Anaesthesiology 259203 259203 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1
Known as Grp DexP-sedation regime with dexmedetomidine as the primary agent.
Dexmedetomidine up to 1 to 1.5 mcg/kg/hour to achieve desired sedation level. Given via infusion as required for up to a max of 30 days.
Arm 2
Grp Std care- standard care sedation as per site's normal practice. Given via infusion as required.
Intervention code [1] 257878 0
Treatment: Drugs
Comparator / control treatment
The comparator arm of this trial is standard care sedative regime as per the site’s usual practice.
Control group
Active

Outcomes
Primary outcome [1] 261968 0
a comparison of the cumulative and daily dose of administered dexmedetomidine and midazolam in the intervention and the control groups.
This will be assessed via data collected from the medical record.
Timepoint [1] 261968 0
At discharge from intensive care.
Secondary outcome [1] 268889 0
The cumulative and daily dose of propofol, ketamine, fentanyl, morphine, diazepam, clonazepam and other sedatives.
This will be assessed via data collected from the medical record.
Timepoint [1] 268889 0
At discharge from intensive care.
Secondary outcome [2] 268890 0
The proportion of patients in RASS categories -3 to -5, -2 to +1 and +2 to +4, assessed every day in ventilated patients still receiving sedative infusions.
This will be assessed via data collected from the medical record.
Timepoint [2] 268890 0
At cessation from mechanical ventilation.
Secondary outcome [3] 268891 0
The proportion of patients with a positive CAM-ICU and the number of days for which the CAM-ICU is positive
This will be assessed via data collected from the medical record.
Timepoint [3] 268891 0
At discharge from intensive care.
Secondary outcome [4] 268892 0
Duration of mechanical ventilation, ICU and hospital length of stay, mechanical ventilation and ICU free days at day 28.
This will be assessed via data collected from the medical record.
Timepoint [4] 268892 0
At discharge from hospital
Secondary outcome [5] 268893 0
Vital status.
This will be assessed via data collected from the medical record and also patient follow up.
Timepoint [5] 268893 0
at hospital discharge and at 90 days after randomisation
Secondary outcome [6] 268894 0
Composite of death or full time institutional dependency (rehabilitation hospital or nursing home).
This will be assessed via data collected from the medical record and also patient follow up.
Timepoint [6] 268894 0
At 180 day after randomisation
Secondary outcome [7] 268896 0
Assessment of the rate of recruitment of eligible subjects:
a. Proportion of screened and eligible patients who were recruited.
b. Proportion of enrolled patients who were intubated for longer than 24 hours.
c. Duration from time of intubation to time of randomisation and time from randomisation to time of commencement of study medications.
This will be assessed via data collected from the medical record.
Timepoint [7] 268896 0
At study completion.

Eligibility
Key inclusion criteria
Patients eligible for the study must meet these 2 criteria:
The patient is mechanically ventilated via an endotracheal tube and has been intubated, (excluding time spent intubated within an operating or procedural theatre), for less than 12 hours, and the treating clinician believes that:
1. The patient requires immediate AND ongoing sedative medication for comfort, safety, and to facilitate the delivery of life support measures.
2. The choice of the sedative medications needs to be determined now
3. There is uncertainty whether a sedative regimen using dexmedetomidine as the primary agent or the clinicians usual choice of sedative regimen for this patient is superior, AND
4. The patient is expected to remain intubated the day after tomorrow.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if any of the following criteria apply:
- Age less than 18 years,
- Patient is pregnant and/or lactating.
- Patient has a proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, stroke, or hypoxic brain injury.
- Patient has a proven or suspected cervical spinal cord injury or pathology that may result in permanent or prolonged weakness of upper and lower limbs.
- Patient has proven or suspected primary neurological pathology associated with prolonged weakness, such as Guillain-Barre syndrome
- Patient has been admitted as a consequence of a drug overdose
- Patient has burn injuries
- Patient is receiving or expected to need ongoing neuromuscular blockade
- Patient has allergy to propofol or dexmedetomidine
- Patient’s mean arterial blood (MAP) pressure is less than 55 mmHg despite resuscitation and vasopressor therapy
- Patient has a heart rate (HR) less than 55/min unless being treated with a beta blocker
- Patient has a high grade atrio-ventricular block in the absence of a functioning pacemaker
- Patient has end stage liver failure or acute fulminant hepatic failure
- Patient does not speak English
- Death is deemed imminent and inevitable
-Patient is a nursing home resident
- Patient has an underlying disease that makes survival to 90 days unlikely.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A pilot study where patients are allocated to study arm via concealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done in permuted blocks, in a 1:1 ratio to either the dexmedetomidine arm or standard care arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3144 0
New Zealand
State/province [1] 3144 0
Auckland

Funding & Sponsors
Funding source category [1] 258349 0
Commercial sector/Industry
Name [1] 258349 0
Hospira Inc
Address [1] 258349 0
275 North Field Drive, Lake Forest, Illinois 60045
Country [1] 258349 0
United States of America
Primary sponsor type
University
Name
ANZIC-research centre, Monash University
Address
The Alfred Centre
99 Commercial road
Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 257499 0
University
Name [1] 257499 0
ANZIC-research centre, Monash University
Address [1] 257499 0
The Alfred Centre
99 Commercial road
Melbourne Victoria 3004
Country [1] 257499 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260321 0
Ethics committee address [1] 260321 0
Ethics committee country [1] 260321 0
Date submitted for ethics approval [1] 260321 0
10/02/2011
Approval date [1] 260321 0
Ethics approval number [1] 260321 0

Summary
Brief summary
The purpose of the SPICE Pilot RCT is to obtain preliminary data on the feasibility of conducting a large phase III RCT. The hypothesis of the proposed RCT is that a sedation regimen based on dexmedetomidine as the primary sedative agent, and in which benzodiazepine use is minimised, will lead to improved patient centred outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32106 0
Address 32106 0
Country 32106 0
Phone 32106 0
Fax 32106 0
Email 32106 0
Contact person for public queries
Name 15353 0
Belinda Howe
Address 15353 0
ANZIC-research centre, DEPM, Monash University
The Alfred Centre
99 Commercial Road
Melbourne Victoria 3004
Country 15353 0
Australia
Phone 15353 0
+61 3 9903 0340
Fax 15353 0
+61 3 9903 0152
Email 15353 0
belinda.howe@monash.edu
Contact person for scientific queries
Name 6281 0
Dr Yahya Shehabi
Address 6281 0
Associate Professor, University of New South Wales
Clinical School of Medicine
Prince of Wales Hospital, Barker Street, Randwick, NSW 2031
Country 6281 0
Australia
Phone 6281 0
+61 2 9382 4721
Fax 6281 0
+61 2 9382 4870
Email 6281 0
y.shehabi@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results