Modulation of Microbiota Metabolism in Cardiac Surgery Patients
Condition: Multiple Organ Dysfunction
Study type: Interventional

Summary: 
      An imbalance in the microbiota (most often intestinal) largely determines the onset of a
      disease state, and often a critical state. Cardiac surgery accompanied by heart failure and
      hypoperfusion is a proven risk factor for the development of metabolic disorders of the
      intestinal flora and bacterial translocation. Previously, it was shown that the change in
      serum concentrations of phenolic metabolites of the intestinal microbiota reflects the
      dynamics of the severity of the patient's condition and can be used for objective monitoring
      of treatment. Preoperative analysis of microbial metabolites makes it possible to reliably
      identify the group of patients with the highest risk of developing postoperative organ
      dysfunctions. In patients with a baseline level of the sum of phenolic acid concentrations
      over 3.5 mmol / L, the likelihood of postoperative complications is 10 times higher (OR -
      10.5; 95% CI 1.35-81.7, p = 0.026). Reducing the metabolic activity of opportunistic bacteria
      and the level of aromatic microbial metabolites associated with sepsis through the
      prophylactic use of antibiotics belonging to the group of protein synthesis inhibitors at the
      level of bacterial cell ribosomes is of great interest.
    

Detailed description: 
      MMMMODCS (Modulation of Microbiota Metabolism Multiple Organ Dysfunctions in Cardiac Surgery)
      is a single-center clinical study, during which it is planned to study the safety and
      efficacy of the perioperative use of antibiotic inhibitors of protein synthesis at the
      ribosome level of bacterial cells (hereinafter: antibiotic inhibitors) in patients with high
      the risk of developing multiple organ dysfunction (MOD) of infectious genesis. The high-risk
      group is represented by patients who are planned to have surgery on the thoracoabdominal
      aorta; combined operations on coronary vessels and heart valves; patients with initially low
      heart ejection fraction (less than 45%). The study was designed to find out if the
      prophylactic use of a combination of antibiotic inhibitors prevents an increase in
      concentration (or contributes to a decrease with an initial increase) of aromatic microbial
      metabolites (AMM) above 3.5 mmol / L and the development of MOD, requiring a long stay in an
      intensive care unit more than 6 days). After signing an informed consent prior to surgery,
      patients will be randomized into one of two cohorts: with or without a combination of
      antibiotic inhibitors.

      In a cohort with prophylactic treatment, in addition to standard antibiotic prophylaxis (I,
      II generation cephalosporins), combinations of the following antibiotic inhibitors
      (Doxycycline or Rimfampicin + Gentamicin or Clarithromycin) will be used orally or
      intravenously, depending on the patient's condition.

      The AMM level will be measured in blood serum samples on a gas chromatography-mass
      spectrometer before the operation, on the 3rd and 6th days after the operation. The rest of
      the indicators will be discussed at the same points.
    

Intervention name(s): cardiac surgery
Intervention type(s): Procedure
Intervention description(s): prophylactic use of antibiotic-inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In group I, antibiotics-inhibitors of microbial metabolism are used in the perioperative period and the next 2 postoperative days The second group uses standard antibiotic prophylaxis
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: microbiota;; sepsis;; antibiotics;; cardiac surgery