Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256022
Status:
WITHDRAWN
Last Update Posted:
2015-11-20
First Post:
2005-11-17
Brief Title:
The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients
Sponsor:
Melbourne Health
Organization:
Melbourne Health
Study Overview
Official Title:
The Effect of Prophylactic Pre Operative Probiotic Therapy on Peri Operative Endotoxin Levels in Cardiac Surgery Patients
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to delays with logistics and protocol revision not viable to continue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 patientsLactobacilli have been reported as effective in counteracting gram negative bacteria in the gutThus 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
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 patientsLactobacilli have been reported as effective in counteracting gram negative bacteria in the gutThus 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
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 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 AcidophilusLactobacillus Fermentum Lactobacillus Fermentum and Lactobacillus Acidophilus and Placebo
The probioticplacebo 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 operativelyA total of 30 mls of blood is required
Two different lactobacillus strains will be assessed in the study Lactobacillus Acidophilus and Lactobacillus Fermentum There are 4 treatment groups in this study Lactobacillus AcidophilusLactobacillus Fermentum Lactobacillus Fermentum and Lactobacillus Acidophilus and Placebo
The probioticplacebo 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 operativelyA total of 30 mls of blood is required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None