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The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Melbourne Health.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Intensive Care Unit Research Department, Royal Melbourne Hospital
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00256022
First received: November 17, 2005
Last updated: July 12, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention
Preoperative Cardiac Surgery Patients
Drug: Lactobacillus Probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Effect of Prophylactic Pre Operative Probiotic Therapy on Peri Operative Endotoxin Levels in Cardiac Surgery Patients.

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • The primary outcome variable of this study is endotoxin rise in the first 24 hours post commencement of surgery.

Secondary Outcome Measures:
  • The secondary outcomes include peak IL-6 levels, the development of post operative generalised inflammation and low systemic vascular resistance.

Estimated Enrollment: 40
Study Start Date: July 2007
Estimated Study Completion Date: December 2007
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for cardiac surgery requiring cardiopulmonary bypass will be approached for consent to participate in the study.

Exclusion Criteria:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256022

Contacts
Contact: Julian Hunt-Smith +61 3 93427441 julian.hunt-smith@mh.org.au
Contact: Deborah Barge +61 3 93427710 deborah.barge@mh.org.au

Sponsors and Collaborators
Melbourne Health
Intensive Care Unit Research Department, Royal Melbourne Hospital
Investigators
Principal Investigator: John F Cade Intensive Care Unit, Royal Melbourne Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00256022     History of Changes
Other Study ID Numbers: 2000.177
Study First Received: November 17, 2005
Last Updated: July 12, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on November 20, 2014