Prospective Randomized Study to Assess Impact of Statins in Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Sepsis is a common, expensive, frequently fatal and highly complex inflammatory syndrome wherein multiple cellular and humoral pathways are involved. Since it's a multifactorial syndrome merely blocking one of the various inflammatory pathways may not suffice to provide effective treatment and this may partly explain why most of the adjunctive therapies developed for severe sepsis have yielded disappointing results in rigorous clinical trials. Statins have varied pleiotropic effects on the inflammatory mediators and there addition to the current adjuvant therapies in septic shock may help in reduction of mortality. The present trial aims to study survival benefit and changes in bio-marker levels in septic shock.
Adult patients (>=18 years) in septic shock and admitted to ICU will be included in the study. Patients will be randomized as per computer generated random number into the Drug (Atorvastatin, 40 mg) or matched placebo group. Drug or placebo will be given to selected patient via nasogastric tube for 7 days. Bio markers (Il-6, TNF-alpha) estimated during the trial week (Days 1, 4, and 7). All clinical and study personnel and patients remained blinded to the study group assignment throughout the trial.
详细描述
Objectives:
- Study impact of statins on levels of biomarkers (IL-6 and TNF-α) of sepsis.
- Study survival benefit of statins in septic shock.
Introduction:
Sepsis is the leading cause of mortality in non-coronary ICUs. Mortality associated with sepsis is still considerably high. Rising economic burden of managing sepsis is a major concern. Statin is an anti-hyperlipidemic drug with pleiotropic effects. It has properties like anti-inflammatory/oxidative, immunomodulatory effects, enhances endothelial function, reduction in blood thrombogenicity, and increased nitric oxide (NO) bioavailability. Available evidence suggests that statins may play a positive role in reduction of mortality in sepsis. However, the multidimensional heterogeneous character of the available studies does not allow drawing firm conclusions about its usefulness in sepsis and septic shock. This randomized, double blinded, placebo controlled trial is an attempt to study the impact of statins on mortality and biomarker levels in septic shock.
Details of material and methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical disease of septic shock
- •Aged eighteen years and above
- •Admitted to ICU
排除标准
- •Previous statin induced myopathy or hypersensitivity reaction
- •Greater than two and half times elevated liver transaminases
- •Chronic liver disease
- •Pregnant or lactating mothers
研究组 & 干预措施
Statin
Atorvastatin, 40 mg for 7 days in patients of septic shock admitted to ICU
干预措施: Atorvastatin (Drug)
Placebo
Matched placebo, 40 mg for 7 days in patients of septic shock admitted to ICU
干预措施: Placebo (Drug)
结局指标
主要结局
Mortality
时间窗: 28 day of ICU stay
28 day mortality after inclusion in study.
次要结局
- Vasopressor free days.(28 days after commencement of trial drug.)
- Renal replacement free days.(28 days after commencement of trial drug.)
- Ventilation free days.(28 days after commencement of trial drug.)
- Transfusion free days.(28 days after commencement of trial drug.)
- Cytokines in septic shock(Day 1, 4 and 7 of commencement of trial drug.)
- Total parenteral nutrition free days.(28 days after commencement of trial drug.)