Status:
WITHDRAWN
The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients
Lead Sponsor:
Melbourne Health
Collaborating Sponsors:
Intensive Care Unit Research Department, Royal Melbourne Hospital
Conditions:
Preoperative Cardiac Surgery Patients
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary hypothesis for the study is that pre-operative prophylactic probiotic Lactobacilli tablets will reduce the severity and incidence of endotoxin rise in post cardiopulmonary bypass in cardia...
Detailed Description
The study compare endotoxin levels of post operative cardiac surgery patients who have received pre operative prophylactic probiotic Lactobacillus tablets. Compared to patients who have received a pla...
Eligibility Criteria
Inclusion
- Patients scheduled for cardiac surgery requiring cardiopulmonary bypass will be approached for consent to participate in the study.
Exclusion
- Age greater than or equal to 18 years
- Current usage of a probiotic product
- Past history of asthma or recurrent urticaria, pregnancy, HIV infection, immunosuppression and pre existing intestinal disorder.
- The Lactobacillus acidophilus preparation to be used in this study contains a very small amount of MSG (total dose 20mg/day, equivalent to 10% of the total dose used to test MSG sensitivity) and as a precaution patients with asthma or recurrent urticaria will be excluded. As the Lactobacillus preparation contains live micro organisms, immunosuppressed and pregnant patients will be excluded.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00256022
Start Date
July 1 2007
End Date
December 1 2007
Last Update
November 20 2015
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