Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Sex
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
1/05/2006
Actual
8/05/2006
Date of last participant enrolment
Anticipated
Actual
17/10/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
150
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 9952 0
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
[email protected]
Contact person for scientific queries
Name 880 0
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
[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
EmbaseContinuation of statin therapy in patients with presumed infection: A randomized controlled trial.2011https://dx.doi.org/10.1164/rccm.201006-0955OC
N.B. These documents automatically identified may not have been verified by the study sponsor.