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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02067949

Enrollment

100

Registered

2014-02-20

Start date

2014-02-28

Completion date

2015-03-31

Last updated

2015-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Brief 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.

Detailed description

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

Interventions

DRUGSimvastatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
28 day ICU and hospital mortality	one year

Secondary

Measure	Time frame
Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio	one year

Other

Measure	Time frame	Description
ICU hazards	one year	* Requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation * Total ICU length of stay.(LOS)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026