Modulation of Microbiota Metabolism in Cardiac Surgery Patients

NCT04921436 | Completed

• 1 other identifier: 10031967MM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Organ Dysfunction

Keywords

microbiota;; sepsis;; antibiotics;; cardiac surgery

Outcome Measures

Primary Outcomes (2)

• 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)

  3 - 6 days after surgery

• the duration of stay in the ICU

  the frequency of detecting patients

  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

  6 days after surgery

Study Arms (2)

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.

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)

Interventions

cardiac surgery PROCEDURE

prophylactic use of antibiotic-inhibitors

cardiac surgery patients with preventive treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• 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).

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead
• Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology: collaborator

Study Sites (1)

Petrovsky National Reasearch Centre of Surgery

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Sepsis

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• MAXIM BABAEV, D.Sc.

  Petrovsky National Research Centre of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the first patient gets into the group of preventive therapy, the next one does not get into the group, and so on (1:1)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 10, 2021
• Study Start: October 3, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

RU (1)