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

NCT00256022 | Withdrawn

• 1 other identifier: 2000.177
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Preoperative Cardiac Surgery Patients

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (4)

Lactobacillus Acidophilus Arm

ACTIVE COMPARATOR

The probiotic 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.

Drug: Lactobacillus Probiotic

Lactobacillus Fermentum Arm

ACTIVE COMPARATOR

The probiotic 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.

Drug: Lactobacillus Probiotic

Lactobacillus Fermentum and Lactobacillus Acidophilus

ACTIVE COMPARATOR

The probiotic 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.

Drug: Lactobacillus Probiotic

Placebo

PLACEBO COMPARATOR

The placebo will be given to the patient 2 a day 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.

Other: Lactose Powder

Interventions

Lactobacillus Probiotic DRUG

Lactobacillus Acidophilus Arm; Lactobacillus Fermentum Arm; Lactobacillus Fermentum and Lactobacillus Acidophilus

Lactose Powder OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melbourne Health: lead
• Intensive Care Unit Research Department, Royal Melbourne Hospital: collaborator

Study Officials

• John F Cade

  Intensive Care Unit, Royal Melbourne Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: July 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 20, 2015

Record last verified: 2015-04