Acute Respiratory Distress Network (ARDSNet) Studies 10 and 12 Statins for Acutely Injured Lungs from Sepsis (SAILS)
Accession Number
HLB01201414a
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
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Study Period
2010 - 2013
NHLBI Division
DLD
Date Prepared
December 5, 2014
Last Updated
N/A
Clinical Trial URLs
https://clinicaltrials.gov/ct2/s...
Primary Publication URLs
http://www.ncbi.nlm.nih.gov/pubm...
Study Website
http://www.ardsnet.org/
Consent
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Commercial Use Specimen Restrictions Yes
Non-Genetic Use Specimen Restrictions Based On Area Of Use Yes
Genetic Use Of Specimens Allowed? Yes, For Some Specimens
Genetic Use Area Of Research Restrictions Yes
Specific Consent Restrictions
Non-genetic use of biospecimens is restricted to research involving lung injury, other lung disease or critical care diseases. Use of biospecimens in genetic research is tiered to (1) research in acute respiratory distress syndrome (ARDS), or (2) research in other medical conditions. Biospecimens cannot be used directly to produce commercial products.
Objectives
The SAILS trial was intended to assess the efficacy and safety of oral rosuvastatin in patients with sepsis-induced Acute Lung Injury (ALI) and test the hypothesis that rosuvastatin therapy would improve the clinical outcomes of critically ill patients with sepsis-associated acute respiratory distress syndrome (ARDS).
Background
In ARDS, inflammation in the lungs and other organs can cause life-threatening organ failure. Inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A reductase (statins) can modulate inflammatory responses. Previous observational studies suggested that statins improved clinical outcomes in patients with sepsis.
Subjects
Patients were eligible for enrollment if they were receiving positive-pressure mechanical ventilation through an endotracheal tube, had a ratio of the partial pressure of arterial oxygen (Pao2) to the fraction of inspired oxygen (Fio2) of 300 or less, and had bilateral infiltrates on chest radiography that were consistent with pulmonary edema, without evidence of left atrial hypertension. Additionally, the subjects needed to meet at least one criterion for a systemic inflammatory response: a white blood cell count greater than 12,000 or less than 4,000 or at least 10% band forms, or a core body temperature of more than 38°C or less than 36°C.
Design
Patients were randomly assigned in permuted blocks to receive either enteral rosuvastatin or placebo. A 40 mg loading dose of the study drug was administered within four hours after randomization. Subsequently, maintenance doses of 20 mg were administered daily until the third day after discharge from the intensive care unit, study day 28, hospital discharge, or death, whichever came first. The primary outcome measure was mortality before hospital discharge home or until study day 60 if the patient was still in a health care facility. Secondary outcome measures included the number of ventilator-free days to day 28, organ-failure-free days to day 14, and ICU-free days to day 28.
Conclusions
The study was stopped because of futility after 745 of an estimated 1000 patients had been enrolled. There was no significant difference between study groups in 60 day in-hospital mortality or in mean ventilator-free days. The rosuvastatin group had fewer days free of hepatic or renal failure. Thus, rosuvastatin therapy did not improve clinical outcomes in patients with sepsis-associated ARDS and may have contributed to hepatic and renal organ dysfunction.
Additional Details
rosuvastatin: 379
placebo: 366
|
SAILS placebo |
SAILS rosuvastatin |
All |
||||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
17-20 |
7 |
1.91 |
7 |
1.85 |
14 |
1.88 |
|
21-25 |
8 |
2.19 |
11 |
2.90 |
19 |
2.55 |
|
26-30 |
19 |
5.19 |
20 |
5.28 |
39 |
5.23 |
|
31-35 |
13 |
3.55 |
24 |
6.33 |
37 |
4.97 |
|
36-40 |
27 |
7.38 |
30 |
7.92 |
57 |
7.65 |
|
41-45 |
32 |
8.74 |
27 |
7.12 |
59 |
7.92 |
|
46-50 |
26 |
7.10 |
39 |
10.29 |
65 |
8.72 |
|
51-55 |
51 |
13.93 |
37 |
9.76 |
88 |
11.81 |
|
56-60 |
59 |
16.12 |
46 |
12.14 |
105 |
14.09 |
|
61-65 |
40 |
10.93 |
35 |
9.23 |
75 |
10.07 |
|
65-70 |
32 |
8.74 |
35 |
9.23 |
67 |
8.99 |
|
71-75 |
21 |
5.74 |
23 |
6.07 |
44 |
5.91 |
|
76-80 |
14 |
3.83 |
23 |
6.07 |
37 |
4.97 |
|
81-85 |
14 |
3.83 |
13 |
3.43 |
27 |
3.62 |
|
86-89 |
3 |
0.82 |
9 |
2.37 |
12 |
1.61 |
|
|
SAILS placebo |
SAILS rosuvastatin |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
Female |
185 |
50.55 |
195 |
51.45 |
380 |
51.01 |
|
Male |
181 |
49.45 |
184 |
48.55 |
365 |
48.99 |
|
|
SAILS placebo |
SAILS rosuvastatin |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
Not reported |
10 |
2.73 |
14 |
3.69 |
24 |
3.22 |
|
White |
289 |
78.96 |
301 |
79.42 |
590 |
79.19 |
|
African American |
53 |
14.48 |
52 |
13.72 |
105 |
14.09 |
|
Other |
14 |
3.83 |
12 |
3.17 |
26 |
3.49 |
|
|
SAILS placebo |
SAILS rosuvastatin |
All |
|||
|---|---|---|---|---|---|---|
|
N |
% |
N |
% |
N |
% |
|
|
Hispanic or Latino |
40 |
10.93 |
46 |
12.14 |
86 |
11.54 |
|
Not Hispanic or Latino |
326 |
89.07 |
333 |
87.86 |
659 |
88.46 |
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