Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: sara mostafa amin eladawy
• Treatments: Simvastatin

Criteria

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