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Statins for the Early Treatment of Sepsis (SETS)

Primary Purpose

Sepsis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Simvastatin

Identical-appearing placebo

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Statin, Infection, Immunomodulatory

Eligibility Criteria

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

Inclusion Criteria:

Age > 18 years
Initial presentation to the Emergency Department or University of Chicago MD office/Dialysis Center for current hospital admission
Sepsis (ACCP/SCCM criteria)
1. Clinically suspected infection as per the treating physician or confirmed infection
2. 2 or more of the following: Temperature 38ºC (100.4ºF)or 36ºC (96.8ºF), Heart rate (HR) > 90/min, Respiratory rate (RR) > 20/min or PaCO2 < 32 mmHg, White blood cell count > 12,000/mm3 or < 4000/m3 or > 10%immature neutrophils
Initiation of antibiotics by treating physician for sepsis
Hospitalized from the Emergency Department or University of Chicago MD office/Dialysis Center to an inpatient medical service (intensive care unit (ICU)or non-ICU service) OR admission to the medical ICU (MICU) from a non-ICU inpatient medical floor.
Assent of the primary treating physician at the time of enrollment.
The meeting of SIRS criteria is due to an infection as per the treating physician.

Exclusion Criteria:

Pregnancy
ALT >3 times above the upper limit of normal
Elevated creatine phosphokinase (CPK) (>3 times the upper limit of normal)
Concurrent treatment with any of the following drugs: daptomycin, fenofibrate, ketoconazole,triaconazole, amiodarone, clarithromycin, cyclosporine, erythromycin,nefazodone, niacin, protease inhibitors, telithromycin, verapamil,danazol, gemfibrozil
History of allergy or intolerance to statins
Greater than 16 hours after meeting inclusion criteria
Use of 1 more doses of statins in the previous 4 weeks
Clinical indication for treatment with statin during hospital admission (per treating physician)
Sufficiently poor prognosis prior to enrollment that treating physicians have elected to employ comfort care or plan to discharge to hospice
Transfer from surgical service to medical service
Needing transfusion for either active bleeding or severe hemolysis.

Sites / Locations

The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Simvastatin 80 mg once daily PO (or via NG or G-tube)

Identical-appearing placebo PO (or via NG or G-tube)

Outcomes

Primary Outcome Measures

Time to Clinical Stability

Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.

Secondary Outcome Measures

Full Information

NCT ID

NCT00528580

First Posted

September 11, 2007

Last Updated

August 6, 2018

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT00528580

Brief Title

Statins for the Early Treatment of Sepsis

Acronym

SETS

Official Title

Statins for the Early Treatment of Sepsis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Inadequate recruitment

Study Start Date

February 2008 (Actual)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and clinical outcomes in adults hospitalized with sepsis. As our animal models suggest pretreatment with statins are required for their beneficial effects, we propose a study design intended to identify patients and initiate treatment early in their hospital stay. This Phase II study is intended to assess the feasibility of conducting a large-scale investigator-initiated translational research protocol that involves multiple clinical services within the Department of Medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

Sepsis, Statin, Infection, Immunomodulatory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Simvastatin 80 mg once daily PO (or via NG or G-tube)

Arm Title

Arm Type

Placebo Comparator

Arm Description

Identical-appearing placebo PO (or via NG or G-tube)

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

80 mg once daily PO/NG x 4 days

Intervention Type

Drug

Intervention Name(s)

Identical-appearing placebo

Intervention Description

once daily x 4 days

Primary Outcome Measure Information:

Title

Time to Clinical Stability

Description

Normalization of vital signs for each subject enrolled. This is expressed as a mean time to normalization for each +/- standard error.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years Initial presentation to the Emergency Department or University of Chicago MD office/Dialysis Center for current hospital admission Sepsis (ACCP/SCCM criteria) Clinically suspected infection as per the treating physician or confirmed infection 2 or more of the following: Temperature 38ºC (100.4ºF)or 36ºC (96.8ºF), Heart rate (HR) > 90/min, Respiratory rate (RR) > 20/min or PaCO2 < 32 mmHg, White blood cell count > 12,000/mm3 or < 4000/m3 or > 10%immature neutrophils Initiation of antibiotics by treating physician for sepsis Hospitalized from the Emergency Department or University of Chicago MD office/Dialysis Center to an inpatient medical service (intensive care unit (ICU)or non-ICU service) OR admission to the medical ICU (MICU) from a non-ICU inpatient medical floor. Assent of the primary treating physician at the time of enrollment. The meeting of SIRS criteria is due to an infection as per the treating physician. Exclusion Criteria: Pregnancy ALT >3 times above the upper limit of normal Elevated creatine phosphokinase (CPK) (>3 times the upper limit of normal) Concurrent treatment with any of the following drugs: daptomycin, fenofibrate, ketoconazole,triaconazole, amiodarone, clarithromycin, cyclosporine, erythromycin,nefazodone, niacin, protease inhibitors, telithromycin, verapamil,danazol, gemfibrozil History of allergy or intolerance to statins Greater than 16 hours after meeting inclusion criteria Use of 1 more doses of statins in the previous 4 weeks Clinical indication for treatment with statin during hospital admission (per treating physician) Sufficiently poor prognosis prior to enrollment that treating physicians have elected to employ comfort care or plan to discharge to hospice Transfer from surgical service to medical service Needing transfusion for either active bleeding or severe hemolysis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerry Krishnan, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10991706

Citation

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Results Reference

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Citation

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derived

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Statins for the Early Treatment of Sepsis

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