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Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Simvastatin 40 mg PO or NGT |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Simvastatin 40mg PO or NGT |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Shock Reversal | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Marker Levels | Change in inflammatory marker levels over time from time zero to time 24 hour. | over 24 hours (time zero and time 24 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W Donnino, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02446 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25855898 | Derived | 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. | |
| 24794878 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Statin Group | Simvastatin: Simvastatin 40mg PO or NGT |
| FG001 | Placebo Group | Placebo: Corn Starch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Statin Group | Simvastatin: Simvastatin 40mg PO or NGT |
| BG001 | Placebo Group | Placebo: Corn Starch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Shock Reversal | Posted | Mean | Standard Deviation | hours | up to 7 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Statin Group | Simvastatin: Simvastatin 40mg PO or NGT |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael W. Donnino | Beth Israel Deaconess Medical Center | 6177542341 | mdonnino@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Corn Starch |
|
| 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. |
| 21827677 | Derived | 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. |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Inflammatory Marker Levels | Change in inflammatory marker levels over time from time zero to time 24 hour. | Posted | Mean | Standard Deviation | pg/mL and ng/mL | over 24 hours (time zero and time 24 hours) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo Group | Placebo: Corn Starch | 0 | 10 | 0 | 10 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| TNF-alpha (pg/mL) |
|
| ICAM (ng/mL) |
|
| VCAM (ng/mL) |
|
| eSelectin (ng/mL) |
|