Statin Therapy in the Treatment of Sepsis
Study of Statin Therapy in the Treatment of Sepsis
1 other identifier
interventional
18
1 country
1
Brief Summary
Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2008
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 9, 2008
CompletedFirst Posted
Study publicly available on registry
May 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
May 1, 2017
2.8 years
May 9, 2008
March 10, 2017
May 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Shock Reversal
up to 7 days
Secondary Outcomes (1)
Inflammatory Marker Levels
over 24 hours (time zero and time 24 hours)
Study Arms (2)
1
EXPERIMENTALSimvastatin 40 mg PO or NGT
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Greater than 18 years old
- Hypotensive requiring vasopressors
- Suspected Infection
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02446, United States
Related Publications (3)
Ghosh CC, Thamm K, Berghelli AV, Schrimpf C, Maski MR, Abid T, Milam KE, Rajakumar A, Santel A, Kielstein JT, Ahmed A, Thickett D, Wang K, Chase M, Donnino MW, Aird WC, Haller H, David S, Parikh SM. Drug Repurposing Screen Identifies Foxo1-Dependent Angiopoietin-2 Regulation in Sepsis. Crit Care Med. 2015 Jul;43(7):e230-40. doi: 10.1097/CCM.0000000000000993.
PMID: 25855898DERIVEDDobesh PP, Olsen KM. Statins role in the prevention and treatment of sepsis. Pharmacol Res. 2014 Oct;88:31-40. doi: 10.1016/j.phrs.2014.04.010. Epub 2014 May 2.
PMID: 24794878DERIVEDDonnino MW, Cocchi MN, Salciccioli JD, Kim D, Naini AB, Buettner C, Akuthota P. Coenzyme Q10 levels are low and may be associated with the inflammatory cascade in septic shock. Crit Care. 2011 Aug 9;15(4):R189. doi: 10.1186/cc10343.
PMID: 21827677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael W. Donnino
- Organization
- Beth Israel Deaconess Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Michael W Donnino, MD
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Michael Donnino
Study Record Dates
First Submitted
May 9, 2008
First Posted
May 13, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-05