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Trial registered on ANZCTR


Registration number
ACTRN12606000182594
Ethics application status
Approved
Date submitted
1/05/2006
Date registered
17/05/2006
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective study of predictors of the diagnosis of delirium or future development of the delirium: the association between serum anticholinergic levels and dignosis or future development of delirium in palliative care patients with advanced cancer.
Scientific title
Prospective study of predictors of the diagnosis of delirium or future development of the delirium: the association between serum anticholinergic levels and dignosis or future development of delirium in palliative care patients with advanced cancer.
Secondary ID [1] 288323 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium in advanced cancer 1155 0
Condition category
Condition code
Cancer 1237 1237 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
patients with delirium in advanced cancer. Data collection will be daily from admission to death or discharge.
Intervention code [1] 1011 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1674 0
Association of Serum Anticholinergic Levels (SAL) on admission to palliative care unit and at delirium occurrence with admission diagnosis of delirium or future occurrence during admission of delirium
Timepoint [1] 1674 0
Patients will be followed from admission to palliative care inpatient unit until death or discharge for delirium episdoes.
Secondary outcome [1] 3000 0
i. Association of rating on Clinician rated Anticholinergic Scale – modified version (on admission and daily scores for period of observation) with occurrence of delirium.
Timepoint [1] 3000 0
on admission, daily
Secondary outcome [2] 3001 0
ii.Sensitivity and specificity for SAL (taken on admission and level taken if delirium occurs i.e daily memorial delirium score of 10 or above on daily assessment) for diagnosis of incident and prevalent delirium.
Timepoint [2] 3001 0
on admission, at delirium
Secondary outcome [3] 3002 0
iii.Predictive model of investigational and clinical parameters on admission for incident and prevalent delirium.
Timepoint [3] 3002 0
on admission, at delirium

Eligibility
Key inclusion criteria
i.Admission to a palliative care inpatient unit.ii.male and female patients with Advanced cancer.iii.Predicted survival of greater than 7 days.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i.Non-English speaking background.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 1353 0
University
Name [1] 1353 0
Flinders University
Address [1] 1353 0
Flinders University, Bedford Park, Adelaide South Australia
Country [1] 1353 0
Australia
Funding source category [2] 1354 0
Charities/Societies/Foundations
Name [2] 1354 0
Hopehealthcare research fund
Address [2] 1354 0
Braeside Hospital, 340 Prairievale road Prairiewood 2164
Country [2] 1354 0
Australia
Funding source category [3] 1355 0
Charities/Societies/Foundations
Name [3] 1355 0
Sacred heart palliative care services research fund
Address [3] 1355 0
Darlinghurst Road, Darlinghurst
Country [3] 1355 0
Australia
Primary sponsor type
Hospital
Name
Sacred Heart palliative care services and Flinders University
Address
Flinders University, Bedford Park, Adelaide South Australia
Country
Australia
Secondary sponsor category [1] 1196 0
Government body
Name [1] 1196 0
Hope healthcare
Address [1] 1196 0
Braeside Hospital, 340 Prairievale road Prairiewood 2164
Country [1] 1196 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2711 0
St Vincents hospital
Ethics committee address [1] 2711 0
Ethics committee country [1] 2711 0
Australia
Date submitted for ethics approval [1] 2711 0
Approval date [1] 2711 0
13/03/2006
Ethics approval number [1] 2711 0
H05/102
Ethics committee name [2] 2712 0
Braeside Hospital
Ethics committee address [2] 2712 0
Ethics committee country [2] 2712 0
Australia
Date submitted for ethics approval [2] 2712 0
Approval date [2] 2712 0
18/08/2005
Ethics approval number [2] 2712 0
2005-08-1

Summary
Brief summary
Delirium is common in patients with advanced cancer, and presents with symptoms of disturbed sleep, attention, and/or memory; and restlessness or drowsiness. The cause of this is believed to be due to a disturbance of the cholinergic transmitter system in the brain. This could be due to anticholinergic activity of medication, or substances produced in acute illness. It is not possible to measure these abnormalities in the brain in the clinical setting, so a surrogate marker(s) that is routinely measured would be useful. A serum anticholinergic assay can quantify anticholinergic activity in the blood. We aim to measure this on admission to a palliative care unit, and at an episode of delirium, and look at its levels in relation to its ability to predict the occurrence of delirium. We will also look for associations with other simple clinical and investigational measures, so a model can be developed to more accurately predict those at risk of delirium so preventive strategies and early identification can be utilised.
Trial website
Trial related presentations / publications
Agar M, Draper B, Plummer J, Phillips P, and Currow D. Anticholinergic levels and risk of delirium in advanced cancer. Poster presentation. MASCC International symposium on supportive care in cancer. New York City, June 2012.
Public notes

Contacts
Principal investigator
Name 35748 0
Prof Meera Agar
Address 35748 0
PO Box 123 Ultimo NSW 2007
Office: Level 3, 235 Jones St, Ultimo NSW 2007
Country 35748 0
Australia
Phone 35748 0
+61 2 9514 4243
Fax 35748 0
Email 35748 0
meera.agar@sswahs.nsw.gov.au
Contact person for public queries
Name 10200 0
Prof Meera Agar
Address 10200 0
PO Box 123 Ultimo NSW 2007
Office: Level 3, 235 Jones St, Ultimo NSW 2007
Country 10200 0
Australia
Phone 10200 0
+61 2 9514 4243
Fax 10200 0
o
Email 10200 0
meera.agar@sswahs.nsw.gov.au
Contact person for scientific queries
Name 1128 0
Prof Meera Agar
Address 1128 0
University of Technology Sydney, 235 Jones Street Ultimo 2007
Country 1128 0
Australia
Phone 1128 0
+61 2 9514 4243
Fax 1128 0
+61 2 83829518
Email 1128 0
meera.agar@sswahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary