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Trial registered on ANZCTR


Registration number
ACTRN12605000756628
Ethics application status
Approved
Date submitted
18/11/2005
Date registered
18/11/2005
Date last updated
15/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Continued use of Atorvostatin in sepsis
Scientific title
A phase II randomised controlled trial in patients on statin therapy who develop sepsis to evaluate the effect of continued atorvastatin use on the incidence of severe sepsis
Secondary ID [1] 288332 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis / infection in patients taking statin therapy 912 0
Condition category
Condition code
Blood 979 979 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atorvostatin as continuation of statin therapy for a 28 day study period ( or until discharge form hospital)
Intervention code [1] 763 0
Treatment: Drugs
Comparator / control treatment
Placebo as continuation of statin therapy for a 28 day study period ( or until discharge form hospital).
Control group
Placebo

Outcomes
Primary outcome [1] 1301 0
Incidence of severe sepsis
Timepoint [1] 1301 0
during hospital admission
Secondary outcome [1] 2327 0
28 Day mortality
Timepoint [1] 2327 0
post hospital admission date
Secondary outcome [2] 2328 0
Biological markers of inflammation , lipid profile , oxidative stress.
Timepoint [2] 2328 0
during hospital admission

Eligibility
Key inclusion criteria
All patients with sepsis syndrome who are on statin therapy at the time of admisison to hospital are eligable for inclusion.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, acute liver failure or chronic liver disease ( more than Childs B), patients who are moribund and not expected to survive 24 hrs, patients with rhabdomyolysis or myopathy of any cause. Patients in whom any enteral intake will clearly not be possible within 72 hours.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
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] 1076 0
Other Collaborative groups
Name [1] 1076 0
Australian and New Zealand College of Anaesthetists
Address [1] 1076 0
630 St kilda Road, Melbourne,Australia
Country [1] 1076 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Kruger, Intensive Care Specialist, Princess Alexandra Hospital, Brisbane
Address
Princess Alexandra hospital, Brisbane, Queensland, Australia
Country
Australia
Secondary sponsor category [1] 937 0
None
Name [1] 937 0
NIL
Address [1] 937 0
Country [1] 937 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294171 0
Princess Alexandra Hospital HREC
Ethics committee address [1] 294171 0
Princess Alexandra Hospital
Brisbane, Australia
Ethics committee country [1] 294171 0
Australia
Date submitted for ethics approval [1] 294171 0
16/11/2015
Approval date [1] 294171 0
16/12/2015
Ethics approval number [1] 294171 0

Summary
Brief summary
study completed and the results are now published in the American journal of Respiratory and critical care medicine
Trial website
Trial related presentations / publications
The results of the study have been published : Kruger PS, Harward ML, Jones MA, Joyce CJ, Kostner KM, Roberts MS, Venkatesh B. Continuation of statin therapy in patients with presumed infection: A randomised controlled trial. Am J Respir Crit Care Med 2011;183(6):774-781.

they were presented in part at several meetings including:

8th world congress on Trauma, Shock, Inflammation and Sepsis, Munich, Germany, March 2010. Topic: Statins in sepsis: the first clinical results.

23rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Berlin, Germany. April 2013, Possible mechanisms of action for statins in infection.

International Symposium on Intensive Care and Emergency Medicine, Brussels , March, 2012 and 2011 -Statins in Sepsis,

Public notes

Contacts
Principal investigator
Name 36171 0
A/Prof peter kruger
Address 36171 0
Princess ALexandra Hospital
Country 36171 0
Australia
Phone 36171 0
+61 7 3176 2111
Fax 36171 0
Email 36171 0
peter.kruger@health.qld.gov.au
Contact person for public queries
Name 9952 0
A/Prof Dr Peter Kruger
Address 9952 0
Intensive Care Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 9952 0
Australia
Phone 9952 0
+61 7 32402111
Fax 9952 0
+61 7 32407074
Email 9952 0
peter_kruger@health.qld.gov.au
Contact person for scientific queries
Name 880 0
A/Prof Dr Peter Kruger
Address 880 0
Intensive Care Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 880 0
Australia
Phone 880 0
+61 7 32402111
Fax 880 0
+61 7 32407074
Email 880 0
peter_kruger@health.qld.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