Multiple Organ DysfunctionMMMMODCSNCT04921436
Modulation of Microbiota Metabolism in Cardiac Surgery Patients
A study testing cardiac surgery in people with Multiple Organ Dysfunction, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Organ Dysfunction
- What is being tested?
- cardiac surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 3 Oct 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with aneurysmal aortic disease / aortic rupture;
- patients with ischemic heart disease and dysfunction of the valves;
- patients with initially low heart ejection fraction (less than 45%).
Who cannot join
- tolerance to antibacterial drugs;
- taking oncological chemotherapy drugs;
- taking probiotics and nutritional supplements within the last month;
- intraoperative complications (shock of any etiology, allergic reactions).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Microbiota Metabolism in Cardiac Surgery Patients With at High Risk of Postoperative Multiple Organ Dysfunctions
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.
Read the 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 the high 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 the 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.
- Conditions
- Multiple Organ Dysfunction
- Being tested
- cardiac surgery
- Keywords
- microbiota;, sepsis;, antibiotics;, cardiac surgery
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgeryProcedure or surgery
prophylactic use of antibiotic-inhibitors
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery patients with preventive treatment | Experimental | In addition to standard antibiotic prophylaxis (cefazolin 2 g 60 minutes before skin incision and 2 g 3 times a day after surgery), the following antibiotic regimens will be used perioperatively:
Doxycycline (the day before surgery 200 mg and 100 mg on days 1 and 2 after surgery) or Rimfampicin (150 mg 2 times a day before and after surgery) + Gentamicin (240 mg 3 times a day before and 2 days after surgery) or Clarithromycin (500 mg once daily for up to 2 days after surgery).
The route of administration (oral / intravenous) will depend on the condition of the patient. Receives: Procedure: cardiac surgery |
| cardiac surgery patients without preventive treatment | No intervention | standard antibiotic prophylaxis (cefazolin 2 g 60 minutes before skin incision and 2 g 3 times a day after surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMM level
the frequency of detecting patients with an AMM level in the blood serum of no more than 3.5 μmol / l (according to the results of GC-MS analysis)
Measured: 3 - 6 days after surgery
the duration of stay in the ICU
the frequency of detecting patients
Measured: one week
Secondary outcomes (1)
adverse events associated with taking antibiotics (allergic / anaphylactic reactions); cases of sepsis (according to the criteria of Sepsis-3) / septic shock; patients with SOFA more than 7 points more
the frequency of detecting patients
Measured: 6 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start3 Oct 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Responsible party
- Sponsor
- Investigators
- MAXIM BABAEV, D.Sc., Principal investigator, Petrovsky National Research Centre of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921436
- Sponsor's protocol ID
- 10031967MM
- Acronym
- MMMMODCS
- Status last verified
- Nov 2024
- First submitted
- 24 May 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Microbiota Metabolism in Cardiac Surgery Patients With at High Risk of Postoperative Multiple Organ Dysfunctions
- ClinicalTrials.gov ID
- NCT04921436
- Acronym / sponsor ID
- MMMMODCS / 10031967MM
- Conditions
- Multiple Organ Dysfunction
- Keywords
- microbiota;, sepsis;, antibiotics;, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Collaborators
- Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the high 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 the 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery patients with preventive treatment | Experimental | Procedure: cardiac surgeryIn addition to standard antibiotic prophylaxis (cefazolin 2 g 60 minutes before skin incision and 2 g 3 times a day after surgery), the following antibiotic regimens will be used perioperatively: Doxycycline (the day before surgery 200 mg and 100 mg on days 1 and 2 after surgery) or Rimfampicin (150 mg 2 times a day before and after surgery) + Gentamicin (240 mg 3 times a day before and 2 days after surgery) or Clarithromycin (500 mg once daily for up to 2 days after surgery). The route of administration (oral / intravenous) will depend on the condition of the patient. |
| cardiac surgery patients without preventive treatment | No intervention | –standard antibiotic prophylaxis (cefazolin 2 g 60 minutes before skin incision and 2 g 3 times a day after surgery) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with aneurysmal aortic disease / aortic rupture;
- patients with ischemic heart disease and dysfunction of the valves;
- patients with initially low heart ejection fraction (less than 45%).
Key exclusion criteria (4 listed)
- tolerance to antibacterial drugs;
- taking oncological chemotherapy drugs;
- taking probiotics and nutritional supplements within the last month;
- intraoperative complications (shock of any etiology, allergic reactions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac surgeryprophylactic use of antibiotic-inhibitors | Procedure or surgery | cardiac surgery patients with preventive treatment |
Primary outcome
AMM level
Time frame: 3 - 6 days after surgery
the frequency of detecting patients with an AMM level in the blood serum of no more than 3.5 μmol / l (according to the results of GC-MS analysis)
the duration of stay in the ICU
Time frame: one week
the frequency of detecting patients
1 secondary outcome
adverse events associated with taking antibiotics (allergic / anaphylactic reactions); cases of sepsis (according to the criteria of Sepsis-3) / septic shock; patients with SOFA more than 7 points more
Time frame: 6 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAXIM BABAEV, D.Sc. principal investigator
Petrovsky National Research Centre of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac surgery in people with Multiple Organ Dysfunction, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMM level (time frame: 3 - 6 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.