Statin Therapy in the Treatment of Sepsis

This study is currently recruiting participants.
Verified October 2013 by Beth Israel Deaconess Medical Center
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00676897
First received: May 9, 2008
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Septic Shock
Drug: Simvastatin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Statin Therapy in the Treatment of Sepsis

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Time to Shock Reversal [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IL- 6 Levels [ Time Frame: June 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Simvastatin 40 mg PO or NGT
Drug: Simvastatin
Simvastatin 40mg PO or NGT
Other Name: Zocor
Placebo Comparator: 2
Placebo
Drug: Placebo
Corn Starch

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676897

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02446
Contact: Michael Donnino, MD    617-667-7000    mdonnino@bidmc.harvard.edu   
Principal Investigator: Michael Donnino, MD         
Sub-Investigator: Michael Cocchi, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Michael Donnino, Dr. Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676897     History of Changes
Other Study ID Numbers: 2007P-000257
Study First Received: May 9, 2008
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
statin, sepsis, septic shock, simvastatin

Additional relevant MeSH terms:
Sepsis
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014