Critical Illness Clinical Trial
Official title:
The Clinical Outcome and the Cost-effectiveness Analysis of Simvastatin Plus Standard Therapy Versus Standard Therapy Alone in Critically Ill Septic Patient"
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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