Trauma Injury, Brain Injuries, Abdominal Sepsis, Pancreatitis, Meningitis, Encephalitis, Seizures, Acute Respiratory Distress Syndrome
Conditions
Brief summary
Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).
Interventions
DRUGControl
Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation
DRUGAntiseptic Solution
Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation
DRUGBacteriophage
Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation
Sponsors
Northern State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- invasive mechanical ventilation beyond 48 hours
Exclusion criteria
* hospital - acquired pneumonia * community - acquired pneumoniae * BMI \> 35 kg/cm2 * pregnancy * tracheostomy * reintubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ventilator-associated pneumonia (VAP) | Change from Baseline CPIS at 14 days | CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed |
| Changing of oral and lung microbiomes | Change from Baseline Microbiology researching at 14 days | Microbiology researching samples from oral cavity and trachea. The Gram positive and Gram negative aerobes and anaerobes will be assessed with observing Colony Form Unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ dysfunction | Change from Baseline Sequential Organ Function Assessment at 14 days | Sequential Organ Function Assessment (SOFA) will be using for assessment organ dysfunction Patient examination with Sequential Organ Function Assessment (SOFA). If Sequential Organ Function Assessment more then 2 points Organ dysfunction is present. The hirher value is equal worse outcome |
| Concentration of C - reactive protein (CRP) | Change from Baseline CRP at 14 days | Biomarker of the VAP |
| Concentration of Procalcitonin (PCT) | Change from Baseline PCT at 14 days | Biomarker of the VAP |
| Rate of Mortality | Change from Baseline PCT at 28 days | Mortality for 28 days of a hospitalization |
Countries
Russia
Outcome results
None listed