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Statins for the Early Treatment of Sepsis (SETS)

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ClinicalTrials.gov Identifier: NCT00528580
Recruitment Status : Terminated (Inadequate recruitment)
First Posted : September 12, 2007
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sepsis
Interventions: Drug: Simvastatin
Drug: Identical-appearing placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled 2008-2009 at University of Chicago and Mercy Hosptial in Chicago, IL

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Experimental

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

Simvastatin: 80 mg once daily PO/NG x 4 days

Placebo

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

Identical-appearing placebo: once daily x 4 days


Participant Flow:   Overall Study
    Experimental   Placebo
STARTED   34   34 
COMPLETED   34   34 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Experimental

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

Simvastatin: 80 mg once daily PO/NG x 4 days

Placebo

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

Identical-appearing placebo: once daily x 4 days

Total Total of all reporting groups

Baseline Measures
   Experimental   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   34   68 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      34 100.0%      34 100.0%      68 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (8)   52  (8)   52  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  50.0%      17  50.0%      34  50.0% 
Male      17  50.0%      17  50.0%      34  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   34   34   69 


  Outcome Measures

1.  Primary:   Time to Clinical Stability   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Millie Maleckar
Organization: University of Chicago
phone: 773-702-1472
e-mail: mmalecka@bsd.uchicago.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00528580     History of Changes
Other Study ID Numbers: 15420A
First Submitted: September 11, 2007
First Posted: September 12, 2007
Results First Submitted: May 7, 2018
Results First Posted: June 7, 2018
Last Update Posted: June 7, 2018