Ventilators, Mechanical
Conditions
Keywords
Ventilators; Bacterial Lysates; Microecology; pneumonia
Brief summary
The purpose of this study is to assess the effect of bacterial lysates on respiratory tract microecology in patients with mechanical ventilation and the efficacy of prevention and treatment of ventilator associated pneumonia.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a one-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to Bacterial Lysates( 14mg, once a day) or placebo(once a day).
Interventions
14mg once a day
OTHERnormal saline
14.0ml once a day
Sponsors
Sheng Wang MD PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted to ICU for mechanical ventilation * The expected mechanical ventilation time is more than 72h * Sign the informed consent form when conscious and voluntary, and complete the questionnaire survey and follow-up as required; If it is unable to sign the informed consent form and complete the questionnaire survey and follow-up, the legal representative or guardian can act on behalf of it.
Exclusion criteria
* Ventilator associated pneumonia is known and confirmed * Pregnant or lactating female * Allergic to the active ingredients of bacterial lysates or any excipients listed in the ingredients * Patients with autoimmune diseases * Patients with acute intestinal infection * Patients participating in other clinical studies at the same time * Patients considered unsuitable by other researchers to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAP incidence | 2 weeks | The incidence rate of ventilator associated pneumonia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of human immune status | one week | Immune status Assessment of IgG, IgA, and IgM levels Quantifications of IgG, IgA, and IgM levels were determined by Immunological Turbidity Kits |
| drug resistant bacteria Incidence | one week | The incidence rate of drug resistant bacteria |
| Composition of respiratory bacteria | one week | probiotics and pathogens via NGS analysis |
| survival rate | 28 days | ICU in-hospital mortality and 28 day mortality |
Countries
China
Contacts
Primary ContactSheng Wang, MD, PhD
Outcome results
None listed