Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000405516
Ethics application status
Not yet submitted
Date submitted
14/09/2006
Date registered
15/09/2006
Date last updated
15/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Atorvastatin for Renal Protection After Cardiopulmonary Bypass
Scientific title
A phase II randomised, double-blind, placebo-controlled study of the effect of atorvastatin on postoperative renal function in patients undergoing elective cardiopulmonary bypass
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney injury 1371 0
Cardiac surgery with cardiopulmonary bypass 1372 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
atorvastatin 40mg orally starting morning of surgery pre-pump and the same dose continued daily orally for 3 days post-operatively
Intervention code [1] 1359 0
Treatment: Drugs
Comparator / control treatment
Identical placebo orally starting morning of surgery pre-pump and the same dose continued daily orally for 3 days post-operatively
Control group
Placebo

Outcomes
Primary outcome [1] 2027 0
Acute kidney injury as measured by change in serum creatinine
Timepoint [1] 2027 0
72 hours post-operative.
Secondary outcome [1] 3509 0
Systemic markers of oxidative stress and inflammation, drug toxicity, adverse events, length of stay, need for renal replacement therapy, death.
Timepoint [1] 3509 0
72 hours post-operative and at any time during the period of hospitalization.

Eligibility
Key inclusion criteria
1. Informed consent2. Elective cardiac surgery in males/females3. Planned cardiopulmonary bypass4. >1 risk factors for post-operative renal dysfunction.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Emergent cardiac surgery, cardiac transplant or insertion of device2. Planned off-pump cardiac surgery3. Hypersensitivity, allergy or known intolerance to statins4. Pre-morbid end-stage kidney disease or renal transplant5. Pre-operative ARF, defined as an increase in serum creatinine ³88.4mmol/L (1.0mg/dL) from pre-admission to operation6. Active liver disease or cirrhosis7. Pre-operative unexplained elevation of serum transaminases8. Enrolled in a conflicting study9. Pregnancy10. Age below 18 years11. Pre-operative acute inflammation (e.g. endocarditis)12. Moderate to high-dose steroid therapy (e.g. >10mg prednisone or equivalent per day).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation by central randomization by phone/fax through the hospital pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by pre-operative statin therapy, randomization by randomization table from a statistics book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patient, clinician, surgeon, investigator and data-analysis will be blinded to allocation
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1602 0
Charities/Societies/Foundations
Name [1] 1602 0
Austin Anaesthesia and Intensive Care Trust
Country [1] 1602 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital, Department of Intensive Care
Address
Country
Australia
Secondary sponsor category [1] 1407 0
None
Name [1] 1407 0
N/A
Address [1] 1407 0
Country [1] 1407 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27966 0
Address 27966 0
Country 27966 0
Phone 27966 0
Fax 27966 0
Email 27966 0
Contact person for public queries
Name 10548 0
Dr. Sean M Bagshaw
Address 10548 0
Department of Intensive Care,
Austin Hospital
Heidelberg, VIC
Country 10548 0
Australia
Phone 10548 0
03-9496-3801
Fax 10548 0
03-9496-3992
Email 10548 0
[email protected]
Contact person for scientific queries
Name 1476 0
Prof Rinaldo Bellomo
Address 1476 0
Department of Intensive Care,
Austin Hospital
Heidelberg, VIC
Country 1476 0
Australia
Phone 1476 0
03-9496-5992
Fax 1476 0
03-9496-3992
Email 1476 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Prowle JR, Calzavacca P, Licari E, Ligabo EV, Eche... [More Details] 81600-(Uploaded-07-11-2018-09-53-58)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.