Statin Therapy in the Treatment of Sepsis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00676897 |
Recruitment Status :
Completed
First Posted : May 13, 2008
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Septic Shock | Drug: Simvastatin Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Study of Statin Therapy in the Treatment of Sepsis |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
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 |
- Time to Shock Reversal [ Time Frame: up to 7 days ]
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676897
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02446 |
Principal Investigator: | Michael W Donnino, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Michael Donnino, Dr. Michael Donnino, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00676897 |
Other Study ID Numbers: |
2007P000257 |
First Posted: | May 13, 2008 Key Record Dates |
Results First Posted: | June 14, 2017 |
Last Update Posted: | June 14, 2017 |
Last Verified: | May 2017 |
statin, sepsis, septic shock, simvastatin |
Simvastatin Sepsis Shock, Septic Infections Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Shock |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |