Statin Therapy in the Treatment of Sepsis

Beth Israel Lahey Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Septic Shock

Treatments: Drug: Simvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00676897

2007P000257

Details and patient eligibility

About

Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than 18 years old
• Hypotensive requiring vasopressors
• Suspected Infection

Exclusion criteria

• Pregnant
• Liver Failure (ALT or AST > 120)
• Rhabomyolysis (CPK > 3x normal)
• Comfort care measures status
• Chronic Liver Disease (Cirrhosis)
• Use of Cyclosporin, Digoxin, Statins
• Patients who are unable to take medications by mouth or NGT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Simvastatin 40 mg PO or NGT

Treatment:

Drug: Simvastatin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo