Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001535369
Ethics application status
Approved
Date submitted
19/10/2017
Date registered
6/11/2017
Date last updated
6/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are dehydration and diuretic use more commonly associated with falls in frail, elderly patients compared with the robust elderly?
Scientific title
Comparison of the incidence of dehydration and diuretic use among both frail older and robust older patients who present to the Emergency Department with falls
Secondary ID [1] 293172 0
nil known
Universal Trial Number (UTN)
U1111-1204-0109
Trial acronym
AMM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polypharmacy 305157 0
ageing 305158 0
frailty 305160 0
falls 305233 0
Condition category
Condition code
Injuries and Accidents 304539 304539 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients' demographic, clinical, medications and falls information collected: Edmonton frail scale calculated for patients presenting within a time period of 12 months
Intervention code [1] 299420 0
Not applicable
Comparator / control treatment
Study internally controlled as participants whose Edmonton frail scale result indicated that they were not frail were used as a comparator group to the 'frail' participants
Control group
Active

Outcomes
Primary outcome [1] 303714 0
calculation of proportion of frail participants who were taking diuretics upon presentation using data collected from patients' medical records. Frailty was assessed using the Edmonton Frail Scale: participants were deemed to be frail if their score was greater than, or equal to 8.
Timepoint [1] 303714 0
Calculated upon presentation to ED
Primary outcome [2] 303724 0
Calculation of proportion of frail participants who were dehydrated at presentation. Frailty was assessed using the Edmonton Frail Scale: participants were deemed to be frail if their score was greater than, or equal to 8. Dehydration was defined as either a serum sodium concentration greater than 145 mEq/L or a serum urea:creatinine ratio greater than 100.
Timepoint [2] 303724 0
Assessed at time of presentation to ED
Primary outcome [3] 303725 0
calculation of proportion of frail participants who taking diuretic medication and were dehydrated at presentation. Information on diuretic usage was gained from patients medical records. Frailty was assessed using the Edmonton Frail Scale: participants were deemed to be frail if their score was greater than or equal to 8. Dehydration was defined as either a serum sodium concentration greater than 145 mEq/L or a serum urea:creatinine ratio greater than 100.
Timepoint [3] 303725 0
calculated at point of presentation to ED
Secondary outcome [1] 339951 0
comparison of medication use between frail and robust participant groups by calculation of Drug Burden Index [ie comparison of mean numbers of medications used by frail vs robust participants]
Timepoint [1] 339951 0
calculated at point of presentation to ED
Secondary outcome [2] 340116 0
comparison of proportions of frail vs robust participants with co-morbidities at the time of presentation to the ED: we will calculate percentages of all frail patients with co-morbidities for comparison with the percentage of all robust patients with co-morbidities
Timepoint [2] 340116 0
The Charlson co-morbidity index will be calculated at the point of presentation to the ED

Eligibility
Key inclusion criteria
above 60 years of age and have presented to the ED following a fall: able and willing to give informed consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Below age of 60 years: presenting to ED for a reason other than a fall: unable or unwilling to give informed consent (including in the case of serious injuries)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
comparison of proportions of frail vs robust participants with comorbidities
comparison of mean numbers of medications used by frail vs robust participants
comparison of rates of diuretic medication use by frail vs robust participants
comparison of rates of dehydration upon presentation among frail vs robust participants
comparison of incidence of diuretic medication use and rates of dehydration upon presentation by frail vs robust participants

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
30/03/2013
Date of last data collection
Anticipated
Actual
30/03/2013
Sample size
Target
250
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9208 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 17863 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 297806 0
Self funded/Unfunded
Name [1] 297806 0
unfunded
Country [1] 297806 0
Primary sponsor type
Individual
Name
Alexander Bennet
Address
Royal North Shore Hospital
Pacific Highway
St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 296838 0
None
Name [1] 296838 0
nil
Address [1] 296838 0
nil
Country [1] 296838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298856 0
NSLHD HREC
Ethics committee address [1] 298856 0
Ethics committee country [1] 298856 0
Australia
Date submitted for ethics approval [1] 298856 0
Approval date [1] 298856 0
30/05/2012
Ethics approval number [1] 298856 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78458 0
A/Prof Mark Gillett
Address 78458 0
Emergency Department
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Country 78458 0
Australia
Phone 78458 0
+61 2 9463 2228
Fax 78458 0
Email 78458 0
mgillett@med.usyd.edu.au
Contact person for public queries
Name 78459 0
Mark Gillett
Address 78459 0
Emergency Department
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Country 78459 0
Australia
Phone 78459 0
+61299068123
Fax 78459 0
Email 78459 0
mgillett@med.usyd.edu.au
Contact person for scientific queries
Name 78460 0
Mark Gillett
Address 78460 0
Emergency Department
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Country 78460 0
Australia
Phone 78460 0
+61457829396
Fax 78460 0
Email 78460 0
mgillett@med.usyd.edu.au

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.