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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: April 12, 2016
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 
Overall Participants Analyzed 
[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) [1] [2] 
[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 [1]   NA [1]   NA [2] 
Unknown or Not Reported   14   10   24 
[1] not captured
[2] Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment 
[Units: Participants]
     
United States   379   366   745 
APACHE III Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 92.1  (28.4)   94.8  (27.9)   93.4  (28.2) 
[1] 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.
Primary cause of lung injury [1] 
[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 
[1] Based on coding of primary vs. secondary by the site; data entry errors account for total count discrepancy.
Baseline Shock [1] 
[Units: Participants]
 173   166   339 
[1] 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) .
PaFiO2:FiO2 ratio less than or equal to 200 mm Hg [1] 
[Units: Participants]
 267   253   520 
[1] The number of participants with a P/F ratio of 200 mm Hg or less at baseline.
Hours from intubation to randomization 
[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 


  Outcome Measures
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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


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

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00979121     History of Changes
Other Study ID Numbers: 670
N01HR056179 ( Other Grant/Funding Number: NHLBI )
Study First Received: September 16, 2009
Results First Received: August 22, 2014
Last Updated: April 12, 2016
Health Authority: United States: Food and Drug Administration