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Statin Therapy in the Treatment of Sepsis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676897
First Posted: May 13, 2008
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Donnino, Beth Israel Deaconess Medical Center
Results First Submitted: March 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Septic Shock
Interventions: Drug: Simvastatin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Statin Group Simvastatin: Simvastatin 40mg PO or NGT
Placebo Group Placebo: Corn Starch

Participant Flow:   Overall Study
    Statin Group   Placebo Group
STARTED   8   10 
COMPLETED   8   10 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Statin Group Simvastatin: Simvastatin 40mg PO or NGT
Placebo Group Placebo: Corn Starch
Total Total of all reporting groups

Baseline Measures
   Statin Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   10   18 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (18)   54  (16)   58.72  (17.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  50.0%      3  30.0%      7  38.9% 
Male      4  50.0%      7  70.0%      11  61.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      8 100.0%      10 100.0%      18 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  12.5%      3  30.0%      4  22.2% 
White      7  87.5%      7  70.0%      14  77.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   8   10   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Shock Reversal   [ Time Frame: up to 7 days ]

2.  Secondary:   Inflammatory Marker Levels   [ Time Frame: over 24 hours (time zero and time 24 hours) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Michael W. Donnino
Organization: Beth Israel Deaconess Medical Center
phone: 6177542341
e-mail: mdonnino@bidmc.harvard.edu


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

Responsible Party: Michael Donnino, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676897     History of Changes
Other Study ID Numbers: 2007P000257
First Submitted: May 9, 2008
First Posted: May 13, 2008
Results First Submitted: March 10, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017