Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, China
Nanjing, Jiangsu, China
Location status: Recruiting
Location contact
Hui Chen, Doctor
CONTACT
Lili Huang, Doctor
CONTACT
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, China
Location status: Recruiting
Hui Chen, Doctor
CONTACT
Lili Huang, Doctor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Colistin powder will be solubilised in 0.9% Nacl (75mg per 5 mL), and used for nebulisation twice a day at a dose of 75mg for 3 days
Saline solution of 0.9% sodium chloride (NaCl) will be used as placebo. The equivalent volume of 0.9% NaCl will be placed in the nebuliser and delivered twice a day for 3 days.
Time frame: From randomization to 7 days
the incidence of VAP within 7 days after randomisation
Time frame: From randomization to 28 days
The incidence of VAP within 28 days after randomisation
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 were successfully weaned from mechanical ventilation within 28 days after randomisation.
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 died within 28 days
Time frame: From randomization to day 28
The proportion of patients who were newly diagnosed acute kidney injury (AKI) within 28 days after randomization, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
Contact information is provided by the study sponsor or research team.
Southeast University, China
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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