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The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00164099
Recruitment Status : Terminated (Patients would not take product)
First Posted : September 14, 2005
Last Update Posted : November 1, 2007
Sponsor:
Information provided by:
Beth Israel Medical Center

Brief Summary:

All surgical procedures carry with them the risk of infection. Even a minor infection can extend the hospitalization after cardiac surgery. The average minimum increase in length of stay for a single infection is three days.

One of the many means used to reduce post-operative infections is the preventative, or "prophylactic", administration of antibiotics just before and just after surgery. Because antibiotics, and for that matter surgery itself, alter the body's natural immune and inflammatory responses and the makeup of the bacteria in the intestine, there is a great deal of scientific interest in using the supplementation of bacteria that naturally reside in the intestine. It is felt that by doing so, the alterations in the immune response may be corrected and the patient better able to fight infections. There are studies using probiotics that have demonstrated a reduction in infection rates in patients undergoing abdominal surgery.

Subjects will be patients at high risk for infection including those with any one or more of the following characteristics: over 65 years old, poor heart function (ejection fraction <40), diabetes (insulin dependant or non-insulin dependant), peripheral vascular disease, kidney dysfunction (creatinine level >2mg/dl), obesity (body surface area > 2 m2), low serum protein levels (albumin < 2.5 mg/dl), infection of the heart valve (endocarditis), or on any antibiotics other than standard prophylaxis before surgery.

The safety of these products has been very well established.

Patients who consent to enter the study will receive the synbiotic mix, or a placebo, which comes in a powder that may be mixed with a drink, or washed down into the stomach through the NG tube if the patient is still on a ventilator. Dosing will be initiated within four hours of patient arrival in the Cardiac Surgery Intensive Care Unit and will continue on a twice daily basis for the duration of their admission days. Infection and diarrhea data will be monitored.


Condition or disease Intervention/treatment Phase
Surgical Wound Infection Cystitis Bacteremia Pneumonia Enterocolitis, Pseudomembranous Drug: Synbiotic 2000 Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study
Study Start Date : November 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery


Intervention Details:
  • Drug: Synbiotic 2000
    See protocol - 4 bacteria, 4 fiber mixture


Primary Outcome Measures :
  1. Infection [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Tolerance [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing cardiac surgery, able to consent, and at least one of the following:

    • Age >65 years
    • ejection fraction <=40%
    • diabetes mellitus (insulin requiring and non-insulin requiring)
    • peripheral vascular disease
    • creatinine >=2 mg/dl
    • body surface area >= 2 sq meters
    • endocarditis
    • albumin <=2.5 g/dl
    • on antibiotics for any reason other than operative prophylaxis

Exclusion Criteria:

  • Unable to consent
  • Not meeting inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164099


Locations
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United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
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Principal Investigator: David S Seres, MD Beth Israel Medical Center

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ClinicalTrials.gov Identifier: NCT00164099     History of Changes
Other Study ID Numbers: 224-04
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: September 2006
Keywords provided by Beth Israel Medical Center:
Coronary Artery Bypass
Postoperative Complications
Probiotics
Surgical Wound infection
cystitis
bacteremia
pneumonia
Enterocolitis, Pseudomembranous
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacteremia
Wound Infection
Surgical Wound Infection
Enterocolitis, Pseudomembranous
Enterocolitis
Pneumonia
Cystitis
Surgical Wound
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Wounds and Injuries
Postoperative Complications
Clostridium Infections
Gram-Positive Bacterial Infections