Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000572662
Ethics application status
Approved
Date submitted
10/09/2005
Date registered
4/10/2005
Date last updated
6/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of prophylactic preoperative probiotic therapy on perioperative endotoxin levels in cardiac surgery patients.
Scientific title
The effect of prophylactic preoperative probiotic therapy on perioperative endotoxin levels in cardiac surgery patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery patients. 698 0
Condition category
Condition code
Cardiovascular 774 774 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised double blind placebo-controlled study assessing blood endotoxin levels in cardiac surgery patients requiring cardiopulmonary bypass. This study compares endotoxin levels of post operative cardiac surgery patients who have received pre-operative prophylactic probiotic Lactobacillus tablets compared with patients who have received a placebo. Two different Lactobacillus strains will be assessed in the study, Lactobacillus acidophilus and Lactobacillus fermentum.There are 4 treatment groups in this study:Lactobacillus Fermentum, lactobacillus acidophillus, lactobacillus fermentum and acidophillus and placebo. The lactobacillus/placebo will be given to patients twice a day for between 2 to 7 days pre-operatively.Participation in the study requires six separate blood tests commencing at the start of surgery and continuing for the first 24 hours immediately post-operatively. Each blood test requires 5 mls of blood, with a total blood volume of 30 mls required for the study.
Intervention code [1] 450 0
None
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 985 0
The primary outcome variable of this study is endotoxin rise in the first 24 hours post-commencement of surgery
Timepoint [1] 985 0
Secondary outcome [1] 1860 0
Peak IL-6 levels in the first 24 hours post-operatively.
Timepoint [1] 1860 0
Secondary outcome [2] 1861 0
The development of post-operative generalised inflammation and low systemic vascular resistance in the post-operative period.
Timepoint [2] 1861 0

Eligibility
Key inclusion criteria
Patients scheduled for elective cardiac surgery requiring cardiopulmonary bypass will be approached for consent to participate in the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current usage of a probiotic product (eg Yakult, which is freely available as a foodstuff), past history of asthma or recurrent urticaria, pregnancy, HIV infection, immunosupression and pre-existing intestinal disorder. The Lactobacillus acidophilus preparation to be used in this study contains a very small amount of MSG (total dose 20 mg/day, equivalent to 10% of the initial dose used to test for MSG sensitivity) and as a precaution, patients with asthma or recurrent urticaria will be excluded. As the Lactobacillus preparation contains live microrganisms, immunosupressed and pregnant patients will also be excluded.

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)
Sequentially numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation matrix.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 855 0
Hospital
Name [1] 855 0
Intensive Care Research department Funding, Royal Melbourne Hospital
Country [1] 855 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Unit, RMH
Address
Country
Australia
Secondary sponsor category [1] 722 0
None
Name [1] 722 0
Nil
Address [1] 722 0
Country [1] 722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2120 0
Royal Melbourne Hospital
Ethics committee address [1] 2120 0
Ethics committee country [1] 2120 0
Australia
Date submitted for ethics approval [1] 2120 0
Approval date [1] 2120 0
Ethics approval number [1] 2120 0

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

Contacts
Principal investigator
Name 35573 0
Address 35573 0
Country 35573 0
Phone 35573 0
Fax 35573 0
Email 35573 0
Contact person for public queries
Name 9639 0
Dr Julian Hunt-Smith
Address 9639 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 9639 0
Australia
Phone 9639 0
+61 3 93427710
Fax 9639 0
+61 3 93428812
Email 9639 0
[email protected]
Contact person for scientific queries
Name 567 0
Dr Julian Hunt-Smith
Address 567 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 567 0
Australia
Phone 567 0
+61 3 93427710
Fax 567 0
+61 3 93428812
Email 567 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
No additional documents have been identified.