Statin Therapy in the Treatment of Sepsis

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014