Pneumonia Clinical Trial
Official title:
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 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.
Background:
Despite progress in surgical methodology, infections remain one of the most difficult
post-operative complications to prevent. In cardiac surgery, the presence of an infection
can make the difference between a brief hospital stay and a life-threatening illness. The
average minimum increase in length of stay due to a single infection is three days and can
extend to months. Nationally, the average rate of deep sternal wound infection is 3% and
conduit harvest site infection 1.4%.
Because of the intimate relationship between intestinal bacterial flora and normal gut and
immunologic function, current research is investigating the relationship between the
preservation or augmentation of certain naturally occurring bacterial strains in the
intestine and clinical outcomes, particularly infectious. We propose to examine the efficacy
of immediate post-operative supplementation with a product containing four bacterial strains
and four different fibers, putatively fuel for bacterial growth, in reducing infections.
Until recently, most studies performed with LAB have selected strains for their palatability
and usability in yogurts. For this reason, most studies have been based on LAB, such as
Lactobacillus acidophilus, L.casei, L. delbrueckii och Bifidobacillus adolescentis,
B.bifidum, B.longum and Bifidobacterium infantis, which are common in yogurts and kefirs. It
is only recently that interest has been focused on developing criteria for selecting LAB
based on intraluminal biology, such as the ability to adhere to mucus or mucosal cells, the
ability to ferment resistant fibers, and antioxidant capacity. For example, L.plantarum,
which is often recovered from fermented fruits, vegetables, sourdoughs and silage, has been
demonstrated to have a strong ability to adhere to mucosa and to break down resistant
fibers. L. plantarum is the commonest LAB in human gastrointestinal tract and has shown the
greatest ability of all LAB tested to survive in the gut (106 times that of L.rhamnosus for
example) and activate cytokine secretion after passage through the stomach and the small
intestine.
The clinical impact of a particular LAB is strongly associated with its ability to colonize
the intestinal mucosa. LAB common in dairy products such as yogurts (L.Acidophilus,
L.bulgaris and bifidobacteria) have very limited ability to colonize intestinal mucosal
cells. L.rhamnosus (GG) and even more so L.plantarum (299) have been shown to remain viable
up to 28 days post supplementation. L.plantarum is unique as it uses carbohydrate receptors
(mannose) similar to those of gram-negative bacteria (E.coli, Enterobacter, Klebsiella,
Salmonella, Shigella, Pseudomonas and Vibrio cholerae). L. plantarum has also been shown to
prevent adhesion of enteropathogenic E.coli through induction of mRNA expression for the
intestinal mucins MUC2 and MUC3.
Design of the present study 75 consecutive patients deemed at high risk for post-operative
infection will be prospectively and blindly randomized to one of the following three groups:
1. Lactic acid bacteria and fermentable fiber
2. Fermentable fiber alone
3. Non-fermentable (placebo)
Sachets containing LAB plus fiber, fiber alone, or placebo will be provided by the
manufacturer and will be randomized, coded, and assigned to patients in order. Patients will
begin receiving doses within 4 hours of arrival to the CSICU and will remain on treatment
twice daily for 14 days.
Data collection Infection control data are collected on all patients undergoing cardiac
surgery using established institutional definitions for infections. Incidence of sternal
infections, donor site infections, vein harvest site infection, pneumonia, urinary tract
infection, catheter and blood stream infections, and clostridium difficile colitis will be
considered. In addition, the incidence of diarrhea, defined as stools of liquid or
gelatinous consistency, or more than three stools in one day, will be monitored. Data will
be collected during hospital stay and at one-month follow-up. Finally, C-reactive protein
levels, which are commonly assessed during hospitalizations and used as part of the
assessment for coronary risk, will be drawn pre-operatively and four days post-operatively.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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