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

NCT00256022 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-11-20

No results posted yet for this study

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

Interventions

DRUG

Lactobacillus Probiotic

OTHER

Lactose Powder

Sponsors & Collaborators

  • Intensive Care Unit Research Department, Royal Melbourne Hospital

    collaborator UNKNOWN

  • Melbourne Health

    lead OTHER

Principal Investigators

  • John F Cade · Intensive Care Unit, Royal Melbourne Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Completion
2007-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00256022 on ClinicalTrials.gov