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临床试验/NCT06819462
NCT06819462招募中不适用

Inhaled Colistin to Prevent Ventilator-Associated Pneumonia in Patients With Acute Brain Injury

Southeast University, China1 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2025年4月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
444
试验地点
1
主要终点
Prevention of VAP

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged more than or equal to 18 years and less than 80 years
  • ABI patients admitted to the ICU, including TBI, intracranial haemorrhage, ischaemic stroke, post-cardiac arrest hypoxic-ischaemic encephalopathy or other acute neurological insults
  • Glasgow Coma Scale (GCS) score ≤12
  • Duration of mechanical ventilation more than or equal to 48 hours at enrolment
  • Written informed consent provided by the participant's legally authorised representative.

排除标准

  • patients with suspected or confirmed VAP on the day of enrolment
  • Anticipated extubation within the next 24 hours.
  • Duration of mechanical ventilation exceeding 96 hours prior to enrolment.
  • Patients currently receiving or having recently received (within the preceding 24 hours) polymyxin (administered intravenously and/or via nebulization).
  • Known hypersensitivity to polymyxin.
  • Pregnant or breastfeeding women.
  • Myasthenia gravis.
  • Patient with high risk of death within the first 48h after ICU admission.
  • Advanced-stage solid organ malignancy or hematological malignancy.

研究组 & 干预措施

Control Group

Placebo Comparator

Nebulization was initiated within 24 hours after patient enrollment. Control group received nebulization with an equivalent volume of 0.9% sodium chloride twice daily for 3 consecutive days with a vibrating mesh nebulizer.

干预措施: Inhaled 0.9% sodium chloride (Drug)

Colistin Group

Experimental

Nebulization was initiated within 24 hours after patient enrollment. Experimental group received nebulization with colistin (75 mg per dose) twice daily for 3 consecutive days with a vibrating mesh nebulizer.

干预措施: Inhaled colistin (Drug)

结局指标

主要结局

Prevention of VAP

时间窗: From randomization to 7 days

The incidence of VAP from randomization to day 7.

Prevention of early VAP

时间窗: From randomization to 7 days

the incidence of VAP within 7 days after randomisation

次要结局

  • Changes of CPIS within day 28(from randomization to extubation or day 28, whichever occurs first)
  • Use of systemic antibiotic(From randomization to day 28)
  • Invasive ventilator-free days at 28 days(From randomization to 28 days)
  • Successful of weaning from ventilator(From randomization to 28 days)
  • ICU days at day 28(From randomization to 28 days)
  • Hospital days at day 28(From randomization to 28 days)
  • VAP incidence within 28 days(From randomization to 28 days)
  • Success of SBT(From randomization to first success of SBT)
  • 28-day mortality(From randomization to 28 days)
  • Incidence of AKI(From randomization to day 28)
  • Successful weaning from mechanical ventilation(From randomization to 28 days)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Liu

doctor

Southeast University, China

研究点 (1)

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