Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient
Information source: Ain Shams University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Critical Illness
Intervention: Simvastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: sara mostafa amin eladawy Official(s) and/or principal investigator(s): sara M amin, MSC, Principal Investigator, Affiliation: Ain Shams University
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.
Clinical Details
Official title: The Clinical Outcome and the Cost-effectiveness Analysis of Simvastatin Plus Standard Therapy Versus Standard Therapy Alone in Critically Ill Septic Patient"
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: 28 day ICU and hospital mortality
Secondary outcome: Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio
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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Ain shams university hospital and cairo university hospital, Cairo 11361, Egypt
Additional Information
Starting date: February 2014
Last updated: April 3, 2015
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