Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

Study Overview
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Brief Summary
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determination of the effectiveness and the cost-effectiveness of simvastatin(Zocor 40 mg) plus standard therapy (SSCG)versus standard therapy alone in critically ill septic patient from the societal perspective over one year.

Detailed Description
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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

Official Title
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The Clinical Outcome and the Cost-effectiveness Analysis of Simvastatin Plus Standard Therapy Versus Standard Therapy Alone in Critically Ill Septic Patient

Conditions
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Critical Illness

Intervention / Treatment
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* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: broad spectrum AB +fluids<br>Control group :50 patients will be treated according to SURVIVING SEPSIS CAMPAIGN BUNDLES | |
| Active Comparator: simvastatin<br>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) | Drug: Simvastatin<br>* 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<br>* Other names: Zocor 40 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day ICU and hospital mortality |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio |  | one year |