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"

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Drug: Simvastatin

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11361
    • Ain shams university hospital and cairo university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: broad spectrum AB +fluids; Control group :50 patients will be treated according to SURVIVING SEPSIS CAMPAIGN BUNDLES
Active Comparator: simvastatin; 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; 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; Other Names: Zocor 40 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: sara mostafa amin eladawy
• Investigators: Principal Investigator: sara M amin, MSC, Ain Shams University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 20, 2014

Study Record Updates

• Last Update Posted (Estimate): April 6, 2015
• Last Update Submitted That Met QC Criteria: April 3, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: 1/2014