Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067949
• Other study ID #: 1/2014
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2014
• Last updated: April 3, 2015
• Start date: February 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain shams university hospital and cairo university hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
sara mostafa amin eladawy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ICU hazards	Requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation; Total ICU length of stay.(LOS)	one year	Yes
Primary	28 day ICU and hospital mortality		one year	Yes
Secondary	Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio		one year	Yes