Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

Sponsor

sara mostafa amin eladawy (Other)

Overall Status

Completed

CT.gov ID

NCT02067949

Collaborator

(none)

100

Enrollment

Location

Arms

12.9

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness	Drug: Simvastatin	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

28 day ICU and hospital mortality [one year]

Secondary Outcome Measures

Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio [one year]

Other Outcome Measures

ICU hazards [one year]
Requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation Total ICU length of stay.(LOS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:-

Age >18 and less than 70
Sepsis for less than 24 hours from ICU admission

Exclusion criteria:-

Elderly (defined as older than 70).
Pediatrics (defined as younger than 18).
Pregnancy and nursing.
Unable to receive enteral medications.
History of hypersensitivity to the trial drug.
Are receiving drugs known to interact with simvastatin.
Acute liver failure and chronic liver disease (Child C).
High risk of rhabdomyolysis (multiple traumas, crush injuries, extensive burns(>60%), baseline creatinine kinase (CK) ≥ten-times upper limit of normal.
Patients with dyslipidemia or Prior statin user.
Sever renal impairment (defined as need for replacement therapy )and uncontrolled hypothyroidism
Have a history of known or suspected porphyria
Are unlikely to survive more than 24 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain shams university hospital and cairo university hospital	Cairo		Egypt	11361

Sponsors and Collaborators

sara mostafa amin eladawy

Investigators

Principal Investigator: sara M amin, MSC, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

sara mostafa amin eladawy, teaching assistant, Ain Shams University

ClinicalTrials.gov Identifier:

NCT02067949

Other Study ID Numbers:

1/2014

First Posted:

Feb 20, 2014

Last Update Posted:

Apr 6, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Critical Illness

Simvastatin

Study Results

No Results Posted as of Apr 6, 2015