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临床试验/NCT01550419
NCT01550419Unknown早期 1 期

Effect of Atorvastatin on the Frequency of Ventilator-associated Pneumonia in Patients With Ischemic Stroke

Shanghai Minhang Central Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
100
试验地点
1
主要终点
Cumulative frequency of ventilator-associated pneumonia

研究概览

简要总结

Ventilator-associated pneumonia (VAP) is an important cause of morbidity and mortality in ventilated critically ill patients specially in intensive care unit (ICU). It is associated with an increased duration of mechanical ventilation, high death rates and increased healthcare costs in China. However, VAP is preventable and many practices have been demonstrated to reduce the incidence of this disease, but the morbidity is still so high. So much more methods of prevention should be needed to reduce the incidence of VAP.

Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) present anti-inflammatory and immunomodulatory effects besides their ability to regulate cholesterol composition. So it is hypothesized that early use of statin may prevent some of the infection disease such as VAP.

Actually, Two studies have showed that statin treatment is associated with reduced risk of pneumonia. However, the relationship between statins and reduced risk of pneumonia is not consistent.

After reviewing some of the guidelines,meta analyses and system reviews, the investigator find that advanced age,immune suppression from disease or medication and specially depressed level of consciousness are the risk factors of VAP. So the investigator assumes that early use of statin may give us a favorable outcome in the patients with coma or in the patients with severe disease (Acute Physiology and Chronic Health Evaluation II score > 15 or Glasgow coma score < 7).

In addition there is no prospective study to investigate the role of statins in VAP in the patients with ischemic stroke. The investigator hopes that this study can approve the relationship between statins and reduced risk of VAP in the patients with ischemic stroke. And it can improve the processes,outcomes and costs of critical care as well.

详细描述

This is a one-center, two-arm, randomized, single-blinded, controlled trial. When a patient with ischemic stroke who needs mechanic ventilation is admitted to ICU,a sealed envelop will be opened which decide whether the patient is assigned to the placebo arm or the atorvastatin arm. During they stay in ICU, one tablet of atorvastatin (40mg) or one tablet of placebo will be administered. Atorvastatin or placebo will be administered through an enteral feeding tube or administered orally when patients are able to safely take oral medications.

VAP diagnosis accords with the comprehensive evidence-based clinical practice guidelines for ventilator-associated pneumonia:Diagnosis and treatment which was published in 2008.

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
Single (Participant)

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

  • All consecutive patients with ischemic stroke who are admitted to Intensive Care Unit(ICU) between 1st March.2012 at 00:00 hours (midnight) and the finish date of 31st March. 2014 at 23:59 hours (11.59 pm). Patients who are already in the ICU prior to 1st March. 2012 at 00:00 hours will not be included in the study.
  • Duration of mechanical ventilation > 48h through tracheal tube or tracheotomy
  • Informed consent

排除标准

  • Patients with pneumonia when they are admitted to ICU.
  • Previous use of statin for cholesterol regulation.
  • Chronic liver disease or active liver disease.
  • Increase of CPK (over 3 times the upper limit) during hospitalization.
  • Malnutrition.
  • Pregnancy.
  • Unwilling to continue the therapy during hospitalization.

研究组 & 干预措施

Atorvastatin(50 characters)

Experimental

干预措施: Atorvastatin (Drug)

Placebo(50 characters)

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Cumulative frequency of ventilator-associated pneumonia

时间窗: 30 days

次要结局

  • Mortality(30 days)
  • Ventilation free days(30 days)
  • Antibiotic free days(30 days)
  • Whether the bacteria of multidrug-resistance can be isolated from the sputum culture(30 days)
  • Adverse effects(30 days)

研究者

发起方
Shanghai Minhang Central Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Chunyan

Department of Intensive Care Unit, Minhang Central Hospital

Shanghai Minhang Central Hospital

研究点 (1)

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