Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

NCT02067949 | Completed Phase 3 DMC

• 1 other identifier: 1/2014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 28 day ICU and hospital mortality

  one year

Secondary Outcomes (1)

• Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio

  one year

Other Outcomes (1)

• ICU hazards

  one year

Study Arms (2)

broad spectrum AB +fluids

NO INTERVENTION

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

simvastatin

ACTIVE COMPARATOR

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

Interventions

Simvastatin 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

Also known as: Zocor 40 mg

simvastatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• sara mostafa amin eladawy: lead

Study Sites (1)

Ain shams university hospital and cairo university hospital

Cairo, Cairo Governorate, 11361, Egypt

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• sara M amin, MSC

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: teaching assistant

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 20, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

EG (1)