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OpenTrials
Completed

NCT Number: NCT00676897

Statin Therapy in the Treatment of Sepsis

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

Completed

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02446, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

Simvastatin 40mg PO or NGT

Other names: Zocor

Placebo

Drug

Corn Starch

Primary outcomes

  1. Time to Shock Reversal

    Time frame: up to 7 days

Secondary outcomes

  1. Inflammatory Marker Levels

    Time frame: over 24 hours (time zero and time 24 hours)

    Change in inflammatory marker levels over time from time zero to time 24 hour.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Study of Statin Therapy in the Treatment of Sepsis

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 13, 2008
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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