Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
Scientific title
Circadian disruption after anaesthesia and surgery in patients undergoing cardiac surgery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Circadian disruption following cardiac surgery 3940 0
Sleep disruption following cardiac surgery 3941 0
Condition category
Condition code
Other 4135 4135 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 3655 0
Not applicable
Comparator / control treatment
The within subject design ensures that each subject is their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5025 0
Sleep/ wake cycle disruption, the extent of which is measured using actigraphy and sleep diaries.
Timepoint [1] 5025 0
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.
Primary outcome [2] 5026 0
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.
Timepoint [2] 5026 0
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.
Secondary outcome [1] 8473 0
Mood disturbance, measured using profile of mood states questionnaires
Timepoint [1] 8473 0
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.

Eligibility
Key inclusion criteria
All patients presenting for elective bypass cardiac surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal, non-bypass surgery, patient requiring Magnetic Resonance Imaging at any stage during treatment, congenital heart disease

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 1351 0
New Zealand
State/province [1] 1351 0

Funding & Sponsors
Funding source category [1] 4115 0
University
Name [1] 4115 0
University of Auckland
Country [1] 4115 0
New Zealand
Funding source category [2] 4116 0
Charities/Societies/Foundations
Name [2] 4116 0
Maurice and Phyllis Paykel Equipment Grant
Country [2] 4116 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
University of Auckland
Department of Anaesthesiology
98 Mountain Rd
Epsom
Auckland
1023
Country
New Zealand
Secondary sponsor category [1] 3706 0
None
Name [1] 3706 0
Address [1] 3706 0
Country [1] 3706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6191 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 6191 0
Ministry of Health
354 Victoria St
Hamilton Central
3204
Ethics committee country [1] 6191 0
New Zealand
Date submitted for ethics approval [1] 6191 0
Approval date [1] 6191 0
Ethics approval number [1] 6191 0
NTY/06/08/073

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29103 0
Address 29103 0
Country 29103 0
Phone 29103 0
Fax 29103 0
Email 29103 0
Contact person for public queries
Name 12260 0
Anisoara Jardim
Address 12260 0
Department of Anaesthesiology
Mercy Hospital
98 Mountain Rd
Epsom
Auckland
Country 12260 0
New Zealand
Phone 12260 0
+64 21 705562
Fax 12260 0
Email 12260 0
[email protected]
Contact person for scientific queries
Name 3188 0
Anisoara Jardim
Address 3188 0
Department of Anaesthesiology
Mercy Hospital
98 Mountain Rd
Epsom
1023
Country 3188 0
New Zealand
Phone 3188 0
+64 21 705562
Fax 3188 0
Email 3188 0
[email protected]

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.