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Trial registered on ANZCTR


Registration number
ACTRN12607000028404
Ethics application status
Approved
Date submitted
28/11/2006
Date registered
11/01/2007
Date last updated
3/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Statins in Sepsis Study
Scientific title
A phase II, randomised, placebo-controlled study of the safety, pharmacokinetics and effect on inflammatory marker levels of atorvastatin in intensive care patients with severe sepsis
Secondary ID [1] 253235 0
None
Universal Trial Number (UTN)
Trial acronym
STATInS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Sepsis 1527 0
Condition category
Condition code
Blood 1623 1623 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised allocation of oral or enteral atorvastatin 20mg given daily to a maximum of 28 days (or until discharge from the intensive care unit)
Intervention code [1] 1446 0
Treatment: Drugs
Comparator / control treatment
Randomised allocation of oral or enteral matched placebo (a "dummy" drug or inactive substance which looks the same as the atorvastatin) given daily to a maximum of 28 days (or until discharge from the intensive care unit)
Control group
Placebo

Outcomes
Primary outcome [1] 2240 0
Change in serum interleukin-6 level, a marker of inflammation
Timepoint [1] 2240 0
Measured at day 0,1, 3, 5, 10, 14 and 48 hours post last dose
Secondary outcome [1] 3905 0
Levels of biological markers of oxidative stress, inflammation, lipid profiles
Timepoint [1] 3905 0
Measured at day 0,1,3,5,10,14 and 48 hours post last dose.
Secondary outcome [2] 3906 0
Adverse event frequency
Timepoint [2] 3906 0
Measured continuously throughout studyfor a maximum of 30 days.
Secondary outcome [3] 3907 0
Length of stay in intensive care unit
Timepoint [3] 3907 0
Recorded at 28 days
Secondary outcome [4] 3908 0
Hospital mortality
Timepoint [4] 3908 0
Recorded at 28 days.

Eligibility
Key inclusion criteria
All patients admitted to the intensive care unit with severe sepsis of less than 24 hours duration. Patients must have 3 or more features of systemic inflammatory response syndrome, a strongly suspected or confirmed site of sepsis, presence of organ dysfunction in at least one of the 5 following categories: (cardiovascular system , renal, respiratory, haematologic, unexplained metabolic acidosis).
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Death is imminent, pregnancy or breastfeeding, known history of intolerance to a statin agent, acute liver failure (INR[International Normalised Ratio] greater than 2.5), Child's C classification of liver disease ( a grade of C as measured on the Child-Pugh Classification of Liver Disease, ie very severe liver disease), ALT (alanine transaminase ) > 5 x ULN (Upper Limit of Normal), CK (creatinine kinase) > 5x ULN (Upper Limit of Normal), patient unable to take enteral medication, patient or next of kin/person responsible unable to provide informed consent, patient, family or physician not in favor of aggressive treatment.

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)
Central randomisation by phone/fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation stratified by previous statin use
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects, treating doctors and nurses, data analyst are blinded within this study
Phase
Phase 2
Type of endpoint(s)
Safety
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] 1770 0
Government body
Name [1] 1770 0
National Health and Medical Research Council
Address [1] 1770 0
Level 5
20 Allara Street
Canberra ACT 2061
Country [1] 1770 0
Australia
Primary sponsor type
University
Name
Australia New Zealand Intensive Care Research Centre, a centre of Monash University
Address
Department of Epidemiology and Preventive Medicine (DEPM)
Monash University
The Alfred
Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 1575 0
None
Name [1] 1575 0
NIL
Address [1] 1575 0
Country [1] 1575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3306 0
Princess Alexandra Hospital
Ethics committee address [1] 3306 0
Ethics committee country [1] 3306 0
Australia
Date submitted for ethics approval [1] 3306 0
Approval date [1] 3306 0
Ethics approval number [1] 3306 0
Ethics committee name [2] 3307 0
Royal Darwin Hospital
Ethics committee address [2] 3307 0
Ethics committee country [2] 3307 0
Australia
Date submitted for ethics approval [2] 3307 0
Approval date [2] 3307 0
Ethics approval number [2] 3307 0
Ethics committee name [3] 3308 0
Royal Brisbane Hospital
Ethics committee address [3] 3308 0
Ethics committee country [3] 3308 0
Australia
Date submitted for ethics approval [3] 3308 0
Approval date [3] 3308 0
Ethics approval number [3] 3308 0
Ethics committee name [4] 3309 0
Austin Hospital
Ethics committee address [4] 3309 0
Ethics committee country [4] 3309 0
Australia
Date submitted for ethics approval [4] 3309 0
Approval date [4] 3309 0
Ethics approval number [4] 3309 0
Ethics committee name [5] 3310 0
The Alfred Hospital
Ethics committee address [5] 3310 0
Ethics committee country [5] 3310 0
Australia
Date submitted for ethics approval [5] 3310 0
Approval date [5] 3310 0
Ethics approval number [5] 3310 0
Ethics committee name [6] 3311 0
Frankston Hospital
Ethics committee address [6] 3311 0
Ethics committee country [6] 3311 0
Australia
Date submitted for ethics approval [6] 3311 0
Approval date [6] 3311 0
Ethics approval number [6] 3311 0
Ethics committee name [7] 3312 0
Auckland City Hospital
Ethics committee address [7] 3312 0
Ethics committee country [7] 3312 0
New Zealand
Date submitted for ethics approval [7] 3312 0
Approval date [7] 3312 0
Ethics approval number [7] 3312 0
Ethics committee name [8] 3313 0
Geelong Hospital
Ethics committee address [8] 3313 0
Ethics committee country [8] 3313 0
Australia
Date submitted for ethics approval [8] 3313 0
Approval date [8] 3313 0
Ethics approval number [8] 3313 0
Ethics committee name [9] 3314 0
Bendigo Hospital
Ethics committee address [9] 3314 0
Ethics committee country [9] 3314 0
Australia
Date submitted for ethics approval [9] 3314 0
Approval date [9] 3314 0
Ethics approval number [9] 3314 0
Ethics committee name [10] 260161 0
Monash Medical Centre
Ethics committee address [10] 260161 0
New ethics address. Please modify.
Ethics committee country [10] 260161 0
Australia
Date submitted for ethics approval [10] 260161 0
Approval date [10] 260161 0
Ethics approval number [10] 260161 0
New ethics HREC. Please modify.

Summary
Brief summary
Background:
15,000 people are admitted to an Intensive Care Unit in Australia with severe sepsis every year. One third of these patients will die.
Severe sepsis occurs when an infection causes dysfunction of one or more of the major organs (such as the heart or kidneys). A significant factor in this illness is that the body's normal response to infection or'inflammatory response' becomes abnormal.
The statins are a class of medications commonly used in Australia to lower
cholesterol. Previous research suggests that they may also have a beneficial effect on inflammation and that it may be harmful for people who are already taking statins to stop taking them if they develop severe sepsis.

There is a lack of current information on the effects of these drugs in acute illness
and the risks and benefits of continuing or starting treatment with them in patients
with severe sepsis in the ICU.
The aims of this project are:
To assess the safety profile of atorvastatin in patients with severe sepsis
To assess the effect of atorvastatin on inflammation and the outcome of patients
with severe sepsis
Research Design:
A randomised controlled trial of atorvastatin 20mg versus placebo.
Methods:
Patients in the ICU with severe sepsis who meet the entry criteria will be given 20
mg of atorvastatin (a commerically available medication) or a placebo ("dummy
drug"). The study drug will be given as a capsule by mouth or the contents will be
given mixed with water via a feeding tube. Drug will be given once per day while
the patient is in the ICU to a maximum of 28 days. Safety blood tests to look for
signs of liver or muscle damage will be taken every day. Additional blood tests to
assess inflammation will be taken 6 times during the study. All other care will be
given as standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27380 0
Address 27380 0
Country 27380 0
Phone 27380 0
Fax 27380 0
Email 27380 0
Contact person for public queries
Name 10635 0
Belinda Howe
Address 10635 0
Department of Epidemiology and Preventive Medicine
Monash University
The Alfred
Melbourne Victoria 3004
Country 10635 0
Australia
Phone 10635 0
+61 3 99030340
Fax 10635 0
+61 3 99030556
Email 10635 0
belinda.howe@monash.edu
Contact person for scientific queries
Name 1563 0
Dr Peter Kruger
Address 1563 0
Intensive Care Unit
Princess Alexandra Hospital
Ipswich Road
Woolloongabba Queensland 4102
Country 1563 0
Australia
Phone 1563 0
+61 7 32402111
Fax 1563 0
+61 7 32407074
Email 1563 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