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Statin Therapy in the Treatment of Sepsis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00676897
First received: May 9, 2008
Last updated: May 15, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 Michael Donnino, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Time to Shock Reversal [ Time Frame: up to 7 days ]

Secondary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Boston, Massachusetts, United States, 02446
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Michael W Donnino, MD Beth Israel Deaconess Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Donnino, Dr. Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676897     History of Changes
Other Study ID Numbers: 2007P000257
Study First Received: May 9, 2008
Results First Received: March 10, 2017
Last Updated: May 15, 2017

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

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

ClinicalTrials.gov processed this record on June 23, 2017