Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001540303
Ethics application status
Approved
Date submitted
30/10/2017
Date registered
7/11/2017
Date last updated
10/06/2021
Date data sharing statement initially provided
4/12/2018
Date results information initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Steroids To Reduce the Impact on DElirium study (STRIDE)
Scientific title
Steroids To Reduce the Impact on DElirium (STRIDE) study - pilot randomised controlled trial of preoperative dexamethasone to prevent delirium after hip fracture.
Secondary ID [1] 293218 0
Nil known
Universal Trial Number (UTN)
U1111-1194-9950
Trial acronym
STRIDE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Delirium 305231 0
Hip Fracture 305232 0
Condition category
Condition code
Anaesthesiology 304535 304535 0 0
Anaesthetics
Surgery 304536 304536 0 0
Other surgery
Injuries and Accidents 304537 304537 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexamethasone (20mg) intravenous infusion delivered once (as early as possible after acute admission to hospital)
Intervention code [1] 299475 0
Prevention
Intervention code [2] 299531 0
Treatment: Drugs
Comparator / control treatment
Placebo (sodium chloride 0.9%)
Control group
Placebo

Outcomes
Primary outcome [1] 303773 0
Delirium incidence assessed by the 4A'S test (4AT)
Timepoint [1] 303773 0
Postoperative day 1, 2 and 3
Primary outcome [2] 303774 0
Delirium severity assessed by the Memorial Delirium Assessment Scale (MDAS)
Timepoint [2] 303774 0
Postoperative day 1, 2 and 3 (if delirium is developed on any of these days, MDAS will be assessed daily until it resolves, or until discharged from the orthopaedic ward.
Primary outcome [3] 303816 0
Feasibility issue; participant eligibility
Timepoint [3] 303816 0
Monthly
Secondary outcome [1] 340215 0
Primary outcome; feasibility issue; participant accrual for the trial
Timepoint [1] 340215 0
Monthly
Secondary outcome [2] 340216 0
Primary outcome; feasibility issue; timing of the intervention (how early after admission we are able to deliver the intervention)
Timepoint [2] 340216 0
Monthly
Secondary outcome [3] 340217 0
Primary outcome; feasibility issue; safety
Timepoint [3] 340217 0
Adverse events will be reviewed individually in real-time and in aggregate on a weekly basis. Interim analyses of safety data by independent data monitoring committee after 10, 40 and 80 patients have been enrolled.
Secondary outcome [4] 340218 0
Levels of inflammatory cytokines in blood and cerebrospinal fluid. These samples will be analysed for cytokines and biomarkers previously associated with delirium (S100B, IL-1B, IL-2, IL-6, IL-8, IL-10, IL-13, TNFa, IL-1RA, IFNy, IGF-1, and Cortisol).
Timepoint [4] 340218 0
Blood samples (baseline, day of surgery, postoperative day 1, 2 and 3.
CSF sample (at time of surgery).
Secondary outcome [5] 340297 0
Acute postoperative pain will be assessed with the Numerical Rating Scale (NRS 0-10)
Timepoint [5] 340297 0
Postoperative day 1, 2 and 3
Secondary outcome [6] 340298 0
Length of hospital stay
Timepoint [6] 340298 0
At discharge from hospital
Secondary outcome [7] 340299 0
Mortality rates
Timepoint [7] 340299 0
30 days and 6 months

Eligibility
Key inclusion criteria
65 years and older
Fractured neck of femur
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia or any cognitive deficit
Delirium on admission
Used steroids in the last 7 days
Significant and poorly controlled diabetes (glucose >12 mmol/l on admission)
Systemic infection
Unable to read and speak English

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researcher recruiting patients to the study is blinded to the allocation. Allocation involves contacting the holder of the allocation schedule who is "off-site".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Stratification by age (65-79, 80-89, >90)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 80 participants is the largest sample size that is feasible to recruit from our hospital in a 12-18 month period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2017
Actual
14/11/2018
Date of last participant enrolment
Anticipated
31/03/2020
Actual
19/03/2020
Date of last data collection
Anticipated
30/04/2020
Actual
18/09/2020
Sample size
Target
80
Accrual to date
Final
79
Recruitment outside Australia
Country [1] 9328 0
New Zealand
State/province [1] 9328 0
Auckland

Funding & Sponsors
Funding source category [1] 297845 0
Hospital
Name [1] 297845 0
Waitemata District Health Board
Country [1] 297845 0
New Zealand
Funding source category [2] 301362 0
Government body
Name [2] 301362 0
Health Research Council of New Zealand (HRC)
Country [2] 301362 0
New Zealand
Primary sponsor type
Hospital
Name
Waitemata District Health Board
Address
North Shore Hospital
Private Bag 93503
North Shore, Auckland 0740
Country
New Zealand
Secondary sponsor category [1] 296885 0
None
Name [1] 296885 0
Address [1] 296885 0
Country [1] 296885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298891 0
Health and Desability Ethics Committees
Ethics committee address [1] 298891 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 298891 0
New Zealand
Date submitted for ethics approval [1] 298891 0
25/05/2017
Approval date [1] 298891 0
07/07/2017
Ethics approval number [1] 298891 0
17/NTB/98

Summary
Brief summary
This randomised, placebo-controlled, double-blind clinical trial will include 80 patients aged 65 and over admitted for hip fracture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78582 0
Dr Michal Kluger
Address 78582 0
Waitemata District Health Board
North Shore Hospital
Department of Anaesthesia and Perioperative medicine
Private Bag 93-503
North Shore City, Auckland 0740
Country 78582 0
New Zealand
Phone 78582 0
+64 21 684022
Fax 78582 0
Email 78582 0
[email protected]
Contact person for public queries
Name 78583 0
Dr Michal Kluger
Address 78583 0
Waitemata District Health Board
North Shore Hospital
Department of Anaesthesia and Perioperative medicine
Private Bag 93-503
North Shore City, Auckland 0740
Country 78583 0
New Zealand
Phone 78583 0
+64 21 684022
Fax 78583 0
Email 78583 0
[email protected]
Contact person for scientific queries
Name 78584 0
Dr Michal Kluger
Address 78584 0
Waitemata District Health Board
North Shore Hospital
Department of Anaesthesia and Perioperative medicine
Private Bag 93-503
North Shore City, Auckland 0740
Country 78584 0
New Zealand
Phone 78584 0
+64 21 684022
Fax 78584 0
Email 78584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Version of record online 25/4/2021 Kluger MT, S... [More Details]

Documents added automatically
No additional documents have been identified.