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Statins for Acutely Injured Lungs From Sepsis (SAILS)

This study has been terminated.
(stopped for futility)
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00979121
First received: September 16, 2009
Last updated: October 2, 2014
Last verified: August 2014
Results First Received: August 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Sepsis
Acute Lung Injury
Interventions: Drug: Rosuvastatin
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
No text entered.

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
Rosuvastatin

Half of the subjects will receive the active drug, Rosuvastatin.

Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital.

Placebo

Half of the patients will be randomized to the placebo.

Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital.


Participant Flow:   Overall Study
    Rosuvastatin     Placebo  
STARTED     379     366  
COMPLETED     379     366  
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.
No text entered.

Reporting Groups
  Description
Rosuvastatin

Half of the subjects will receive the active drug, Rosuvastatin.

Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital.

Placebo

Half of the patients will be randomized to the placebo.

Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital.

Total Total of all reporting groups

Baseline Measures
    Rosuvastatin     Placebo     Total  
Number of Participants  
[units: participants]
  379     366     745  
Age  
[units: participants]
     
<=18 years     3     2     5  
Between 18 and 65 years     262     272     534  
>=65 years     114     92     206  
Age  
[units: years]
Mean ± Standard Deviation
  54.2  ± 17.1     54.1  ± 15.6     54.1  ± 16.3  
Gender  
[units: participants]
     
Female     195     185     380  
Male     184     181     365  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     46     40     86  
Not Hispanic or Latino     333     326     659  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     5     6  
Asian     9     7     16  
Native Hawaiian or Other Pacific Islander     2     3     5  
Black or African American     52     53     105  
White     289     301     590  
More than one race     NA [2]   NA [2]   NA [1]
Unknown or Not Reported     14     10     24  
Region of Enrollment  
[units: participants]
     
United States     379     366     745  
Study-Specific Measure [3]
[units: units on a scale]
Mean ± Standard Deviation
  92.1  ± 28.4     94.8  ± 27.9     93.4  ± 28.2  
Study-Specific Measure [4]
[units: participants]
     
Aspiration     26     23     49  
Multiple Transfusion     3     1     4  
Other     7     4     11  
Pneumonia     267     260     527  
Sepsis     72     73     145  
Trauma     2     4     6  
Study-Specific Measure [5]
[units: participants]
  173     166     339  
Study-Specific Measure [6]
[units: participants]
  267     253     520  
Study-Specific Measure  
[units: participants]
     
24 hours or less     124     129     253  
between 24 and 48 hours     204     192     396  
between 48 and 72 hours     41     31     72  
more than 72 hours     10     13     23  
Unknown     0     1     1  
[1] Total not calculated because data are not available (NA) in one or more arms.
[2] not captured
[3] APACHE III Score: Acute, Physiology, Age, Chronic Health Evaluation III Prognostic System is a measure of hospital mortality risk for critically ill adult patients. Our study used a refined version based on the study by Knause and colleagues (Chest, 1991; 100:1619-36). The score is based on results from addition of 3 groups of variables (physiology, range: 0-252; age: 0-23; and chronic health: 0-24). Overall score range: 0-299; higher number indicates higher risk.
[4] Based on coding of primary vs. secondary by the site; data entry errors account for total count discrepancy.
[5] The number of participants who were in shock at the time of randomization. Baseline shock was defined as meeting one of the following conditions: a mean arterial pressure less than 60 mm Hg, receiving a vasopressor (norepinephrine, epinephrine, vasopressin or neosynephrine) at any dose, or receiving dopamine at a dose greater than or equal to 6 mcg/kg/min (or mcg/min) .
[6] The number of participants with a P/F ratio of 200 mm Hg or less at baseline.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hospital Mortality to Day 60.   [ Time Frame: 60 days after randomization ]

2.  Secondary:   Ventilator Free Days at Study Day 28   [ Time Frame: time of initiating unassisted breathing to day 28 after study randomization ]

3.  Other Pre-specified:   Organ Failure Free Days at Day 14   [ Time Frame: 14 days after randomization ]

4.  Other Pre-specified:   ICU Free Days to Day 28   [ Time Frame: 28 days after randomization ]

5.  Other Pre-specified:   Other Secondary Out-comes   [ Time Frame: 28 days after randomization ]

6.  Other Pre-specified:   Changes in Plasma Concentrations of C-reactive Protein (CRP) From Baseline to Day 6 and Day 14   [ Time Frame: 6 and 14 days after randomization ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: David A. Schoenfeld, PhD ARDSNet CCC PI
Organization: ARDS Network
phone: 617-726-6111
e-mail: dschoenfeld@mgh.harvard.edu


No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Publications automatically indexed to this study:

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00979121     History of Changes
Other Study ID Numbers: 670, N01HR056179
Study First Received: September 16, 2009
Results First Received: August 22, 2014
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration