Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

NCT ID: NCT02067949

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-03-31

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

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

broad spectrum AB +fluids

Control group :50 patients will be treated according to SURVIVING SEPSIS CAMPAIGN BUNDLES

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: ACTIVE_COMPARATOR

Simvastatin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Zocor 40 mg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

sara mostafa amin eladawy

OTHER

Sponsor Role: lead

Responsible Party

sara mostafa amin eladawy

teaching assistant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

sara M amin, MSC

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain shams university hospital and cairo university hospital

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

1/2014

Identifier Type: -

Identifier Source: org_study_id