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NCT00164099 · ClinicalTrials.gov registry record · Phase 4
The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study
A Phase 4 study, sponsored by Beth Israel Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT00164099 is a Phase 4 study that was terminated before completion, run by Beth Israel Medical Center. The registered enrollment target is 40 participants.
The verdict
NCT00164099, a Phase 4 study, was terminated before completion, sponsored by Beth Israel Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study 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 moni
Interventions
- DRUG Synbiotic 2000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-11 |
| Est. Completion | 2007-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00164099
The ClinicalTrials.gov registry entry for NCT00164099 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Medical Center, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Synbiotic 2000 is the first listed.
NCT00164099 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00164099 about?
NCT00164099 is a clinical study titled "The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study". 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 prev...
What is the current status of trial NCT00164099?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2005-11. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00164099?
The interventions under investigation include: Synbiotic 2000 (DRUG).
Who is sponsoring clinical trial NCT00164099?
This trial is sponsored by Beth Israel Medical Center, which has 44 total clinical trials registered on ClinicalTrials.gov.
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