Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

Phase 3CompletedNCT02067949

sara mostafa amin eladawy100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Critical Illness

Interventions

SimvastatinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion criteria:- 1. Age \>18 and less than 70 2. Sepsis for less than 24 hours from ICU admission Exclusion criteria:- 1. Elderly (defined as older than 70). 2. Pediatrics (defined as younger than 18). 3. Pregnancy and nursing. 4. Unable to receive enteral medications. 5. History of hypersensitivity to the trial drug. 6. Are receiving drugs known to interact with simvastatin. 7. Acute liver failure and chronic liver disease (Child C). 8. High risk of rhabdomyolysis (multiple traumas, crush injuries, extensive burns(\>60%), baseline creatinine kinase (CK) ≥ten-times upper limit of normal. 9. Patients with dyslipidemia or Prior statin user. 10. Sever renal impairment (defined as need for replacement therapy )and uncontrolled hypothyroidism 11. Have a history of known or suspected porphyria 12. Are unlikely to survive more than 24 hours

Locations (1)

Ain shams university hospital and cairo university hospital

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

28 day ICU and hospital mortality

Time frame: one year

Secondary Outcomes

Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio

Time frame: one year

Data from ClinicalTrials.gov

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