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Statin Therapy in the Treatment of Sepsis

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Simvastatin
Placebo
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring statin, sepsis, septic shock, simvastatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Simvastatin 40 mg PO or NGT

Placebo

Outcomes

Primary Outcome Measures

Time to Shock Reversal

Secondary Outcome Measures

Inflammatory Marker Levels
Change in inflammatory marker levels over time from time zero to time 24 hour.

Full Information

First Posted
May 9, 2008
Last Updated
May 15, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00676897
Brief Title
Statin Therapy in the Treatment of Sepsis
Official Title
Study of Statin Therapy in the Treatment of Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
statin, sepsis, septic shock, simvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Simvastatin 40 mg PO or NGT
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
Simvastatin 40mg PO or NGT
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Corn Starch
Primary Outcome Measure Information:
Title
Time to Shock Reversal
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Inflammatory Marker Levels
Description
Change in inflammatory marker levels over time from time zero to time 24 hour.
Time Frame
over 24 hours (time zero and time 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W Donnino, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25855898
Citation
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.
Results Reference
derived
PubMed Identifier
24794878
Citation
Dobesh 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.
Results Reference
derived
PubMed Identifier
21827677
Citation
Donnino 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.
Results Reference
derived

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Statin Therapy in the Treatment of Sepsis

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