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

NCT00164099 | Terminated Phase 4

• 1 other identifier: 224-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Infection; Cystitis; Bacteremia; Pneumonia; Enterocolitis, Pseudomembranous

Keywords

Coronary Artery Bypass; Postoperative Complications; Probiotics; Surgical Wound infection; cystitis; bacteremia; pneumonia; Enterocolitis, Pseudomembranous

Outcome Measures

Primary Outcomes (1)

• Infection

  3 months

Secondary Outcomes (1)

• Tolerance

  2 weeks

Interventions

Synbiotic 2000 DRUG

See protocol - 4 bacteria, 4 fiber mixture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to consent

Sponsors & Collaborators

• Beth Israel Medical Center: lead

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Cystitis; Bacteremia; Pneumonia; Enterocolitis, Pseudomembranous; Postoperative Complications

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• David S Seres, MD

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: November 1, 2005
• Study Completion: June 1, 2007
• Last Updated: November 1, 2007

Record last verified: 2006-09

Locations

US (1)