Statin Therapy in the Treatment of Sepsis

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT00676897

First received: May 9, 2008

Last updated: July 19, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2008

Last Updated Date

July 19, 2011

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to Shock Reversal [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00676897 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Statin Therapy in the Treatment of Sepsis

Official Title ^ICMJE

Study of Statin Therapy in the Treatment of Sepsis

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Septic Shock

Intervention ^ICMJE

Drug: Simvastatin
Simvastatin 40mg PO or NGT

Other Name: Zocor
Drug: Placebo
Corn Starch

Study Arm (s)

Experimental: 1
Simvastatin 40 mg PO or NGT

Intervention: Drug: Simvastatin
Placebo Comparator: 2
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00676897

Other Study ID Numbers ^ICMJE

2007P-000257

Has Data Monitoring Committee

Yes

Responsible Party

Michael W. Donnino, MD, Beth Israel Deaconess Medical Center

Study Sponsor ^ICMJE

Beth Israel Deaconess Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael W Donnino, MD

Beth Israel Deaconess Medical Center

Information Provided By

Beth Israel Deaconess Medical Center

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top