Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000903280
Ethics application status
Approved
Date submitted
15/10/2009
Date registered
19/10/2009
Date last updated
19/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
How does the anti-sickness drug dexamethasone influence the immune function in healthy volunteers?
Scientific title
The influence of antiemetic doses of dexamethasone on lymphocyte sub-populations in healthy volunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune function 252006 0
Condition category
Condition code
Anaesthesiology 252200 252200 0 0
Anaesthetics
Inflammatory and Immune System 252216 252216 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose dexamethasone 2mg.4mg or 8 mg in 50 mls of normal saline infused over 15 minutes in healthy volunteers
Intervention code [1] 241417 0
Treatment: Drugs
Comparator / control treatment
50 mls of normal saline infused over 15 minutes in healthy volunteers
Control group
Placebo

Outcomes
Primary outcome [1] 253079 0
Proportions of lymphocyte subpopulations on blood analysis
Timepoint [1] 253079 0
Baseline, 4 hours, 24 hours and 168 hours after administration of drug
Secondary outcome [1] 257925 0
Serum Macrophage Inhibitory Factor concentrations
Timepoint [1] 257925 0
Baseline, 4 hours, 24 hours and 168 hours after administration of drug

Eligibility
Key inclusion criteria
Healthy volunteers in American Society of Anaesthesiologists Classification (ASA) I-II
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.Current drug therapy with antiemetics, steroids or serotonergic antidepressants 2.Active infection known or suspected metastatic disease
3.Previous chemotherapy treatment 4.Allergy/intolerance to any of the study drugs (including renal or hepatic impairment, active peptic ulcer disease, ischaemic heart disease, QT prolongation, major psychiatric illness)
5.Diabetes mellitus or history of seizures 6.Participation in any other research trial 7.Pregnant or possibility of

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243888 0
Hospital
Name [1] 243888 0
Royal Perth Hospital
Country [1] 243888 0
Australia
Primary sponsor type
Individual
Name
Clinical A/Professor Tomas Corcoran
Address
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, GPO Box X2213, Perth, W.A. 6847.
Country
Australia
Secondary sponsor category [1] 251229 0
Individual
Name [1] 251229 0
Dr Lisa Hill
Address [1] 251229 0
c/o
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, GPO Box X2213, Perth, W.A. 6847.
Country [1] 251229 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244000 0
Royal Perth Hospital
Ethics committee address [1] 244000 0
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, GPO Box X2213, Perth, W.A. 6847.
Ethics committee country [1] 244000 0
Australia
Date submitted for ethics approval [1] 244000 0
01/06/2009
Approval date [1] 244000 0
07/06/2009
Ethics approval number [1] 244000 0
EC 2008/194

Summary
Brief summary
Dexamethasone is a drug commonly given to prevent postoperative nausea and vomiting. It also has properties that dampen the body's immune response to infection. In this study, we propose to examine healthy volunteers who were either given placebo or dexamethasone in 2mg, 4mg or 8 mg. Blood samples were taken before and after the intervention to determine the effect that they have on the immune system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30391 0
Address 30391 0
Country 30391 0
Phone 30391 0
Fax 30391 0
Email 30391 0
Contact person for public queries
Name 13638 0
Clinical A/Professor Tomas Corcoran
Address 13638 0
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, GPO Box X2213, Perth, W.A. 6847.
Country 13638 0
Australia
Phone 13638 0
+618 9224 1036
Fax 13638 0
Email 13638 0
[email protected]
Contact person for scientific queries
Name 4566 0
Clinical A/Professor Tomas Corcoran
Address 4566 0
Department of Anaesthesia and Pain Medicine, Royal Perth Hospital, GPO Box X2213, Perth, W.A. 6847
Country 4566 0
Australia
Phone 4566 0
+618 9224 1036
Fax 4566 0
Email 4566 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
SourceTitleYear of PublicationDOI
EmbaseAntiemetic doses of dexamethasone and their effects on immune cell populations and plasma mediators of inflammation resolution in healthy volunteers.2018https://dx.doi.org/10.1016/j.plefa.2018.11.004
N.B. These documents automatically identified may not have been verified by the study sponsor.