Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient
The Clinical Outcome and the Cost-effectiveness Analysis of Simvastatin Plus Standard Therapy Versus Standard Therapy Alone in Critically Ill Septic Patient"
研究概览
详细说明
Prospective double blinded randomized controlled study Will be carried out at Ain-Shams university hospital Method: - After approval of the research ethics committee of Ain shams University and obtaining consent from each patient, 100 patients newly admitted to the intensive care unit (ICU) diagnosed to have sepsis/severe sepsis defined by American College of Chest Physicians (ACP) *will be randomized by the clinical pharmacist using a computer-generated randomization sequence with a block size of four into two groups.
Group I (Control group):-50 patients will be treated according to "Surviving Sepsis Campaign guidelines (SSCG) (Dellinger, et al. 2013) Group II (Intervention group):-50 patients will be treated according SSCG plus simvastatin.
Outcomes:- Primary outcome measures: 28 day ICU and hospital mortality.
Secondary Outcome Measures:
- Requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation
- Total ICU length of stay.(LOS)
- Number of patients alive 3, 6, and 12 months
- Incremental cost effectiveness ratio
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Cairo、埃及、11361
- Ain shams university hospital and cairo university hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:-
- Age >18 and less than 70
- Sepsis for less than 24 hours from ICU admission
Exclusion criteria:-
- Elderly (defined as older than 70).
- Pediatrics (defined as younger than 18).
- Pregnancy and nursing.
- Unable to receive enteral medications.
- History of hypersensitivity to the trial drug.
- Are receiving drugs known to interact with simvastatin.
- Acute liver failure and chronic liver disease (Child C).
- High risk of rhabdomyolysis (multiple traumas, crush injuries, extensive burns(>60%), baseline creatinine kinase (CK) ≥ten-times upper limit of normal.
- Patients with dyslipidemia or Prior statin user.
- Sever renal impairment (defined as need for replacement therapy )and uncontrolled hypothyroidism
- Have a history of known or suspected porphyria
- Are unlikely to survive more than 24 hours
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：broad spectrum AB +fluids
Control group :50 patients will be treated according to SURVIVING SEPSIS CAMPAIGN BUNDLES
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有源比较器：simvastatin
50 patients will be treated according SSCG plus simvastatin as single oral tablet 40 mg / day begin with inclusion in the study and continue until hospital discharge .If the patient is able to swallow; the tablet will be given orally.
Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube.
(White R, Bradnam V, 2013)
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single oral tablet 40 mg / day If the patient is able to swallow; the tablet will be given orally.
Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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28 day ICU and hospital mortality
大体时间：one year
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one year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio
大体时间：one year
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one year
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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ICU hazards
大体时间：one year
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one year
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合作者和调查者
调查人员
- 首席研究员：sara M amin, MSC、Ain Shams University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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