The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients
Recruitment status was Not yet recruiting
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 cardiac surgery patients.
Endotoxins are large heat stable lipopolysaccharides, which are found in the cell wall of gram negative bacteria. It has been assumed that the intestinal bacteria are the primary source of the plasma endotoxin in cardiac surgery patients.Lactobacilli have been reported as effective in counteracting gram negative bacteria in the gut.Thus Lactobacilli may be effective in reducing the endotoxin rise associated with cardiopulmonary bypass, which may potentially reduce the incidence of the syndrome of generalised inflammation and low systemic vascular resistance post cardiopulmonary bypass.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||The Effect of Prophylactic Pre Operative Probiotic Therapy on Peri Operative Endotoxin Levels in Cardiac Surgery Patients.|
- The primary outcome variable of this study is endotoxin rise in the first 24 hours post commencement of surgery.
- The secondary outcomes include peak IL-6 levels, the development of post operative generalised inflammation and low systemic vascular resistance.
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||December 2007|
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 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 Acidophilus,Lactobacillus Fermentum, Lactobacillus Fermentum and Lactobacillus Acidophilus and Placebo.
The probiotic/placebo will be given to the patient 2 a dy for between 2-7 days preoperatively. Participation in this study requires 6 separate blood tests commencing at the start of surgery and continuing for 24 hours immediately post operatively.A total of 30 mls of blood is required.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256022
|Contact: Julian Hunt-Smith||+61 3 email@example.com|
|Contact: Deborah Barge||+61 3 firstname.lastname@example.org|
|Principal Investigator:||John F Cade||Intensive Care Unit, Royal Melbourne Hospital|