Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04921436 |
| Other study ID # |
10031967MM |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 3, 2021 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Petrovsky National Research Centre of Surgery |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
