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The goal of this observational study is to investigate whether intravenous polymyxin B combined with nebulisation achieves better antimicrobial efficacy and clinical outcomes than intravenous use alone in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia. The main questions it aims to answer are:
Researchers will compare the differences in blood and ELF drug concentrations, clinical outcomes, and incidence of side effects between two groups of patients, to see if is it necessary to assist with polymyxin B nebulization therapy in patients with multidrug-resistant gram-negative bacilli infected with ventilator-associated pneumonia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous combined with nebulized polymyxin B | The intravenous combined nebulization patient group was divided into two subgroups based on the different doses received -25mg q12h and 50mg q12h. Patients in the intravenous combination nebulized polymyxin B group received a total medication dose of 1.25 to 1.5mg/kg, of which 25-50mg was used for nebulization and the remaining portion was used for intravenous administration. The specific method of nebulization is to receive nebulized bronchodilator 30 minutes before nebulization, add 25-50mg of polymyxin B to 5ml of physiological saline for dilution, use a vibrating mesh nebulizer to connect to the patient's ventilator pipeline suction tube, do not change the original ventilator parameter settings, and continue nebulization for 30 minutes. After 30 minutes, regardless of whether there is any residue of the nebulized drug, it will be discarded according to general nursing methods. |
| |
| Intravenous polymyxin group B | This group of patients received intravenous injection of polymyxin B alone, with intravenous doses of 1.25-1.5mg/kg of polymyxin B administered every 12 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nebulized polymyxin B | Drug | The experimental group received intravenous combined nebulization of polymyxin B |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration | Blood concentration | 3 days after the end of the patient's first medication use |
| ELF concentration | Drug concentration in ELF solution | 3 days after the end of the patient's first medication use |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day clinical cure rate | the proportion of subjects who are thought as clinical effectiveness 28 days after treatment with polymyxin B to the number of subjects in each group. | 28 days after the end of the patient's medication |
| 28-day microbiological cure rate |
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Inclusion Criteria:
Exclusion Criteria:
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Screening of patients with multiple drug-resistant bacterial infections and ventilator-associated pneumonia admitted to the Intensive Care Department of Affiliated Zhongda Hospital of Southeast University. Based on the medical decisions of clinical physicians, they received intravenous administration of polymyxin B alone and intravenous combination nebulization of polymyxin B. Patients were divided into two groups according to the actual treatment methods of polymyxin B.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingzi Huang, MD | Contact | +86-025-83262552 | yz_huang@126.com | |
| Jianfeng Xie, MD | Contact | +86-025-83262552 | xie820405@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingzi Huang, MD | Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital Affiliated to Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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the proportion of subjects of microbiological cure to the number of subjects in each group 28 days after treatment with polymyxin B. |
| 28 days after the end of the patient's medication |
| 28-day adverse reaction rate | the proportion of subjects who experienced adverse reactions within 28 days after treatment with polymyxin B to the number of subjects in each group | 28 days after the end of the patient's medication |
| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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