Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000856910
Ethics application status
Approved
Date submitted
11/08/2011
Date registered
11/08/2011
Date last updated
30/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of remote ischaemic preconditioning on the immune response in healthy volunteers
Scientific title
A paired-analysis trial investigating the effect of remote ischaemic preconditioning compared with no remote ischaemic preconditioning on inflammatory cytokine production and leukocyte function in healthy volunteers
Secondary ID [1] 262816 0
Nil
Universal Trial Number (UTN)
U1111-1123-6538
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The intervention is primarily intended for use in cardiac surgery patients 270535 0
Condition category
Condition code
Cardiovascular 270695 270695 0 0
Coronary heart disease
Surgery 270696 270696 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A blood pressure cuff will be placed on the non-dominant upper arm and inflated to 200 mmHg for five minutes, then deflated for five minutes. This cycle will be repeated three times, taking a total of thirty minutes.
Intervention code [1] 269163 0
Treatment: Other
Comparator / control treatment
No treatment. A blood pressure cuff will be placed on the non-dominant upper arm for thirty minutes, but not inflated.
Control group
Active

Outcomes
Primary outcome [1] 269408 0
Serum levels of inflammatory cytokines (interleukin 4, 6, 8, 10, and 17, monocyte chemoattractant protein 1 and interferon gamma) assessed via cytometric bead assay and flow cytometry
Timepoint [1] 269408 0
Pre-treatment and 20 minutes, 1 hour and 4 hours post-treatment
Primary outcome [2] 269409 0
Changes in the size and activation state of leukocyte populations, as determined using flow cytometry
Timepoint [2] 269409 0
Pre-treatment and 20 minutes, 1 hour and 4 hours post-treatment
Primary outcome [3] 269410 0
Changes in neutrophil function via measurement of the respiratory burst following stimulation, and expression levels of cell surface markers of activation using flow cytometry
Timepoint [3] 269410 0
Pre-treatment and 1 hour post-treatment
Secondary outcome [1] 287576 0
Identification of the cellular source of cytokine production (interleukin 6, 8 and 10) via intracellular cytokine staining using blood samples and flow cytometry
Timepoint [1] 287576 0
Pre-treatment and 1 hour post-treatment
Secondary outcome [2] 287577 0
Serum levels of C-reactive protein
Timepoint [2] 287577 0
Pre-treatment, and 20 minutes, 1 hour and 4 hours post-treatment
Secondary outcome [3] 287578 0
Changes in T-cell function via measurement of proliferation and cytokine production
Timepoint [3] 287578 0
Pre-treatment and 1 hour post-treatment

Eligibility
Key inclusion criteria
Healthy volunteers that have received a tetanus vaccine or booster within the last 10 years
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Peripheral vascular disease
Smoking
Regular use of medication
Acute illness (within 1 week of the study visits)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be sent an information sheet about the study and informed consent will be obtained prior to treatment on the day of the first study visit. All participants will receive the control treatment first, and then the remote ischaemic preconditioning one week later, therefore there are no procedures in place for allocation of patients to treatment groups or concealment of treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study is similar in design to a crossover trial; however, because the effects of remote ischaemic preconditioning have been reported to persist for several weeks, the trial has been designed such that all subjects receive the control treatment first, and the preconditioning seven days later.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 3779 0
New Zealand
State/province [1] 3779 0

Funding & Sponsors
Funding source category [1] 269640 0
Charities/Societies/Foundations
Name [1] 269640 0
Wellington Medical Research Foundation
Country [1] 269640 0
New Zealand
Funding source category [2] 269641 0
Charities/Societies/Foundations
Name [2] 269641 0
The Heart Foundation
Country [2] 269641 0
New Zealand
Primary sponsor type
Individual
Name
Jenni Williams
Address
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 266674 0
None
Name [1] 266674 0
Address [1] 266674 0
Country [1] 266674 0
Other collaborator category [1] 252195 0
Individual
Name [1] 252195 0
A/Prof Anne La Flamme
Address [1] 252195 0
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
Country [1] 252195 0
New Zealand
Other collaborator category [2] 252196 0
Individual
Name [2] 252196 0
Prof Richard Beasley
Address [2] 252196 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country [2] 252196 0
New Zealand
Other collaborator category [3] 252197 0
Individual
Name [3] 252197 0
Dr Paul Young
Address [3] 252197 0
Intensive Care Unit
Wellington Hospital
Private Bag 7902
Wellington South 6242
Country [3] 252197 0
New Zealand
Other collaborator category [4] 252198 0
Individual
Name [4] 252198 0
Dr Janine Pilcher
Address [4] 252198 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country [4] 252198 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269585 0
The Central Regional Ethics Committee
Ethics committee address [1] 269585 0
PO Box 5013
Wellington 6145
Ethics committee country [1] 269585 0
New Zealand
Date submitted for ethics approval [1] 269585 0
24/05/2011
Approval date [1] 269585 0
23/09/2011
Ethics approval number [1] 269585 0
CEN/11/06/034

Summary
Brief summary
There is evidence that remote ischaemic preconditioning (RIPC) protects organs from the effects of decreased blood supply during procedures such as heart surgery. Currently it is not known how this protection occurs, but it appears that RIPC may affect inflammation. This study will investigate the effects of RIPC on the immune system in healthy volunteers. The RIPC takes 30 minutes in total and involves inflation of a blood-pressure cuff on the upper arm for five minutes, temporarily preventing blood flow, followed by deflation for five minutes. This process is repeated three times. Participants will undergo a control session where a blood pressure cuff will be placed on the upper arm for 30 minutes without inflation. Seven days later a treatment session will take place where the blood pressure cuff is placed on the same arm and RIPC is performed. At each of these sessions samples of blood will be collected prior to placement of the blood pressure cuff, and at 20 minutes, 1 hour and 4 hours following. Blood will be analysed by looking for changes in immune cells and markers of inflammation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33002 0
Miss Jenni Williams
Address 33002 0
School of Biological Sciences, Victoria University of Wellington, PO Box 600, Wellington 6140
Country 33002 0
New Zealand
Phone 33002 0
+64 27 227 0220
Fax 33002 0
Email 33002 0
[email protected]
Contact person for public queries
Name 16249 0
Miss Jenni Williams
Address 16249 0
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
Country 16249 0
New Zealand
Phone 16249 0
+64 4 463 5233 x7125
Fax 16249 0
Email 16249 0
[email protected]
Contact person for scientific queries
Name 7177 0
Miss Jenni Williams
Address 7177 0
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
Country 7177 0
New Zealand
Phone 7177 0
+64 4 463 5233 x7125
Fax 7177 0
Email 7177 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
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