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Trial registered on ANZCTR
Registration number
ACTRN12608000640303
Ethics application status
Approved
Date submitted
6/11/2008
Date registered
17/12/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Circadian disruption after anaesthesia and surgery in patients undergoing cardiac surgery.
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Scientific title
Circadian disruption after anaesthesia and surgery in patients undergoing cardiac surgery.
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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:
Circadian disruption following cardiac surgery
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Sleep disruption following cardiac surgery
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Condition category
Condition code
Other
4135
4135
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Patients undergoing cardiac surgery have their sleep/ wake cycles actigraphically measured, their core body temperature rhythms and salivary melatonin measured and recorded and their mood assessed. This takes place in three seperate stages, each a week long. They are monitored pre-operatively, post-operatively in hospital and post-discharge.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
The within subject design ensures that each subject is their own control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Sleep/ wake cycle disruption, the extent of which is measured using actigraphy and sleep diaries.
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Assessment method [1]
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Timepoint [1]
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Three sets of measurements are taken - five to seven days pre-operatively, five to seven days immediately post-operatively and five to seven days immediately post-discharge. One sleep diary of one week is completed at each stage.
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Primary outcome [2]
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Circadian disruption, measured using vitalsense core body temperature monitoring equipment and salivary melatonin. Changes in melatonin levels and core body temperature show the extent, if any, of circadian disruption.
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Assessment method [2]
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Timepoint [2]
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The three to four days of pre-operative core body temperature data, three to four days of post-operative data and three to four days of post-discharge data are collected. Salivary melatonin is also collected at nine half-hour intervals once at every stage. The pre-operative results are then compared to the post-operative to establish melatonin onset time and changes in core body temperature levels - these measurements are compared one week post-discharge.
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Secondary outcome [1]
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Mood disturbance, measured using profile of mood states questionnaires
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Assessment method [1]
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Timepoint [1]
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The profile of mood states questionnaire is taken one week pre-operatively, one week post-operatively and one week post-discharge. The results of the questionnaires are compared one week post-discharge.
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Eligibility
Key inclusion criteria
All patients presenting for elective bypass cardiac surgery
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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
Refusal, non-bypass surgery, patient requiring Magnetic Resonance Imaging at any stage during treatment, congenital heart disease
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/12/2006
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Actual
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Date of last participant enrolment
Anticipated
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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
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Auckland
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Address [1]
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University of Auckland
7 Symonds St
Auckland Central
1010
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Country [1]
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New Zealand
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Maurice and Phyllis Paykel Equipment Grant
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Address [2]
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University of Auckland
7 Symonds St
Auckland Central
1010
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Country [2]
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
University of Auckland
Department of Anaesthesiology
98 Mountain Rd
Epsom
Auckland
1023
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Country
New Zealand
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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]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern Y Regional Ethics Committee
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Ethics committee address [1]
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Ministry of Health
354 Victoria St
Hamilton Central
3204
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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Approval date [1]
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Ethics approval number [1]
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NTY/06/08/073
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Summary
Brief summary
Sleep, controlled by the sleep homeostat and the circadian clock, is essential. In the hospital environment, sleep can be disrupted. This disruption may be attributable to an effect on the sleep homeostat, the circadian clock, or both. The consequences of sleep disruption due to hospitalisation, surgery and anaesthesia may include delayed post-operative recovery. Here, we measure sleep/ wake cycles, mood states and two different markers of circadian rhythms in a surgical population to determine any changes that may occur in the hospital environment.
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Anisoara Jardim
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Address
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Department of Anaesthesiology
Mercy Hospital
98 Mountain Rd
Epsom
Auckland
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Country
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New Zealand
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Phone
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+64 21 705562
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Anisoara Jardim
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Address
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Department of Anaesthesiology
Mercy Hospital
98 Mountain Rd
Epsom
1023
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Country
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New Zealand
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Phone
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+64 21 705562
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
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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