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临床试验/NCT00702130
NCT00702130已完成早期 1 期

The Effect of Pravastatin on the Incidence and in the Natural Course of Ventilatory Associated Pneumonia in the Intensive Care Unit Patients

University of Thessaly2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2008年6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
状态
已完成
入组人数
152
试验地点
2
主要终点
Length of hospitalization in the Intensive Care Unit, morbidity in the Intensive Care Unit

研究概览

简要总结

Statins present anti-inflammatory and immunomodulatory effects. They may modify the regulation of cytokines, (released from the cellular damage) and may reduce the production of C-reactive protein levels. It has been hypothesized that these pleiotropic characteristic of statins might be useful in the management of various diseases, including pneumonia. Indeed, a recent study showed that statin treatment is associated with reduced risk of pneumonia in diabetic patients. However, the relationship between statins and reduced risk of pneumonia is not consistent . In addition there is no prospective study to investigate the role of statins in severe forms of pneumonia such as the VAP.

On this base the investigators aim to study prospectively the effect of statins on the outcome of patients with VAP in the ICU settings. The investigators therefore contacted a double open label randomized trial to investigate whether the use of pravastatin reduces the incidence of Ventilator Associated Pneumonia in the ICU and whether it is related with favorable outcome of patients with Ventilator Associated Pneumonia.

详细描述

INTRODUCTION

The pneumonia in the intensive care unit (I.C.U.) constitutes the most frequent infection and is most often associated with the application of the mechanical ventilation. VAP (Ventilator - Associated Pneumonia) is defined as the nosocomial pneumonia in a patient on mechanical ventilatory support (by endotracheal tube or tracheostomy) for more than 48 hours. The risk for such complication is proportionally increased with the duration of hospitalization. The symptoms include the appearance of pulmonary infiltrate, fever, leukocytosis and purulent tracheobronchial secretions although this symptomatology is not always present. VAP is usually caused by several nosocomial species, such as Acinetobacter baumanni (the most often), Pseudomonas aeruginosa, Klebsiella pneumoniae.

VAP is frequently complicated with the entry of bacteria in the circulation of blood resulting in bacteremia and sepsis. In this respect, this disorder is associated with substantial morbidity and devastating costs of hospitalization. Notably, the cost of one episode of VAP is estimated in 57000 $ per occurrence.

On this basis, several strategies have been implicated to minimize the risk of VAP and to manage effectively the disease (5-12). Among these, antinflammatory treatment has been used in the past to influence the course of and to alter favorably the outcome of VAP (13).

Statins (HMG-CoA-reductase inhibitors), are drugs that regulates the speed of composition of cholesterol suspending the composition of cholesterol in very precocious stage. Recent studies have brought in the surface new attributes of statins. Statins present anti-inflammatory and immunomodulatory effects. They may modify the regulation of cytokines, (released from the cellular damage) and they may reduce the production of C-reactive protein levels (14-19). It has been hypothesized that these pleiotropic characteristic of statins might be useful in the management of various diseases (20), including pneumonia. Indeed, a recent study showed that statin treatment is associated with reduced risk of pneumonia in diabetic patients (18). However, the relationship between statins and reduced risk of pneumonia is not consistent (19). In addition there is no prospective study to investigate the role of statins in severe forms of pneumonia such as the VAP. We therefore contacted a double open label randomized trial to investigate whether the use of pravastatin reduces the incidence of Ventilator Associated Pneumonia in the ICU and whether it is related with favorable outcome of patients with Ventilator Associated Pneumonia.

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 (Investigator)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence in Intensive Care Unit

排除标准

  • Pregnancy,
  • Pneumonia, previous use of statins,
  • Contraindications to statin use (liver dysfunction, SGOT/SGPT > 100 U/L),
  • Increased CPK (over 3 times the upper limit), (for non trauma patients) on admission,
  • Increase of CPK (over 5 times the upper limit) during hospitalization,
  • Use of substances that contraindicates simultaneous use of statins (macrolides, cyclosporine, antipyrin, cholestyramine, gemfibrosil, warfarin),
  • Malabsorption syndrome (over the first 48 hours).

研究组 & 干预措施

A

Experimental

this arm will receive Pravastatin 40 mg per os daily

干预措施: Pravastatin (Drug)

结局指标

主要结局

Length of hospitalization in the Intensive Care Unit, morbidity in the Intensive Care Unit

时间窗: 1 year

次要结局

  • Severity of Ventilator Associated Pneumonia(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Efstratios Manoulakas

Ph

University of Thessaly

研究点 (2)

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