Preoperative Cardiac Surgery PatientsNCT00256022
The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients
A study testing Lactobacillus Probiotic and Lactose Powder in people with Preoperative Cardiac Surgery Patients, run by Melbourne Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Cardiac Surgery Patients
- What is being tested?
- Lactobacillus Probiotic and Lactose Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for cardiac surgery requiring cardiopulmonary bypass will be approached for consent to participate in the study.
Who cannot join
- 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.
About this study
Official title: The Effect of Prophylactic Pre Operative Probiotic Therapy on Peri Operative Endotoxin Levels in Cardiac Surgery Patients.
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.
Read the 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.
- Conditions
- Preoperative Cardiac Surgery Patients
- Being tested
- Lactobacillus Probiotic, Lactose Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus ProbioticDrug
Lactose PowderOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Lactose Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startJul 2007
- Study completionDec 2007 (estimated)
Why it stopped: Due to delays with logistics and protocol revision not viable to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Cardiac Surgery PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- Intensive Care Unit Research Department, Royal Melbourne Hospital
- Investigators
- John F Cade, Principal investigator, Intensive Care Unit, Royal Melbourne Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256022
- Sponsor's protocol ID
- 2000.177
- Status last verified
- Apr 2015
- First submitted
- 17 Nov 2005
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prophylactic Pre Operative Probiotic Therapy on Peri Operative Endotoxin Levels in Cardiac Surgery Patients.
- ClinicalTrials.gov ID
- NCT00256022
- Acronym / sponsor ID
- 2000.177
- Conditions
- Preoperative Cardiac Surgery Patients
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to delays with logistics and protocol revision not viable to continue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- Intensive Care Unit Research Department, Royal Melbourne Hospital
- Study start
- Jul 2007
- Study completion
- Dec 2007 (estimated)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus Acidophilus Arm | Active comparator | Drug: Lactobacillus ProbioticThe 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. |
| Lactobacillus Fermentum Arm | Active comparator | Drug: Lactobacillus ProbioticThe 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. |
| Lactobacillus Fermentum and Lactobacillus Acidophilus | Active comparator | Drug: Lactobacillus ProbioticThe 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. |
| Placebo | Placebo comparator | Other: Lactose PowderThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for cardiac surgery requiring cardiopulmonary bypass will be approached for consent to participate in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus Probiotic | Drug | Lactobacillus Acidophilus Arm, Lactobacillus Fermentum Arm, Lactobacillus Fermentum and Lactobacillus Acidophilus |
| Lactose Powder | Other | Placebo |
Primary outcome
The primary outcome variable of this study is endotoxin rise in the first 24 hours post commencement of surgery.
1 secondary outcome
The secondary outcomes include peak IL-6 levels, the development of post operative generalised inflammation and low systemic vascular resistance.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F Cade principal investigator
Intensive Care Unit, Royal Melbourne Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus Probiotic and Lactose Powder in people with Preoperative Cardiac Surgery Patients, run by Melbourne Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome variable of this study is endotoxin rise in the first 24 hours post commencement of surgery.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.