Inhaled placebo
DrugInhalation of drugs was started within 24 hours after the screening of patients. Both groups inhaled with vibrating mesh spray twice a day for 3 days. The NS group inhaled with normal saline .
NCT Number: NCT06819462
Ventilator associated pneumonia is the most common manifestation of hospital acquired infections in ICU. The incidence of ventilator-associated pneumonia in patients receiving mechanical ventilation is as high as 20% -71%, which can lead to increased systemic antibiotic use, prolonged mechanical ventilation time and ICU stay, and increased treatment costs. In addition, ventilator-associated pneumonia is also the main cause of hospital infection related deaths in critically ill patients.
However, there is a certain buffer time for patients to develop ventilator-associated pneumonia after receiving endotracheal intubation. Previous studies have found that the peak incidence occurs after 7 days of mechanical ventilation, so there is an opportunity for early treatment to prevent infection. Despite the implementation of numerous preventive measures for ventilator-associated pneumonia over the decades, such as reducing sedation and withdrawal protocols, patient positioning, oral care, prophylactic probiotics, prophylactic antibiotics, and the use of silver plated endotracheal tubes. Among them, the research on the preventive use of antibiotics has a history of over 30 years and is a topic of substantial debate. Prophylactic use of antibiotics includes systemic application and local nebulization inhalation, and inhaled antibiotics may be an effective measure for preventing ventilator-associated pneumonia. Potential extensively drug-resistant Gram negative (XDR-GN) bacteria, such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii, are common pathogens causing VAP in ICU. The mortality rate of VAP caused by XDR-GN pathogen may be higher than 70%. With the increasing incidence of multidrug-resistant microorganisms, nebulized or inhaled aminoglycoside antibiotics are often used as empirical or definitive treatment for VAP in ICU patients. The previous group of antibiotics, polymyxin, has returned to the view of medical staff. Sodium polymyxin E methanesulfonate has been used as a salvage therapy for XDR-GN bacteria causing pneumonia, demonstrating its activity against XDR-GN causing VAP in critically ill patients. The guidelines of the Infectious Diseases Society of America (IDSA) on hospital acquired pneumonia also indicate that patients with Gram negative pneumonia caused by drug-resistant bacteria are sensitive to polymyxins. In this randomized controlled study, we aim to investigate the effect of prophylactic use of polymyxin E nebulized inhalation on the incidence of VAP.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inhalation of drugs was started within 24 hours after the screening of patients. Both groups inhaled with vibrating mesh spray twice a day for 3 days. The NS group inhaled with normal saline .
Inhalation of drugs was started within 24 hours after the screening of patients. Both groups used vibrating mesh spray twice a day for 3 days. The Polymyxin E group inhaled polymyxin, 75 mg bid.
Other names: Inhaled
Time frame: From randomization to 7 days
The incidence of VAP from randomization to day 7.
Time frame: From randomization to 28 days
Incidence of VAP from randomization to day 28
Time frame: from randomization to extubation or day 28, whichever occurs first
Changes of clinical pulmonary infection scores after randomization(CPIS)
Time frame: From randomization to day 28
The number of days of systemic antibiotic use and the daily dose of antibiotics administered within 28 days after randomization.
Time frame: From randomization to first success of SBT
The number of days from randomization to the first successful spontaneous breathing test(SBT)
Time frame: From randomization to 28 days
Days alive without endotracheal intubation and invasive mechanical ventilation
Time frame: From randomization to 28 days
The proportion of patients who Successfully weaned from mechanical ventilator within 28 days.
Time frame: From randomization to 28 days
The number of ICU days within 28 days after randomization
Time frame: From randomization to 28 days
The number of Hospital days within 28 days after randomization
Time frame: From randomization to 28 days
The proportion of patients who are died within 28 days
Time frame: From randomization to day 28
The proportion of patients who were newly diagnosed AKI within 28 days after randomization
Southeast University, China
Other
Inhalaed Polymyxin E to Prevent Ventilator-associated Pneumonia: a Multicenter Clinical Study
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