Acute Respiratory Distress Network (ARDSNet) Studies 10 and 12 Statins for Acutely Injured Lungs from Sepsis (SAILS)

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Accession Number
HLB01201414a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
2010 - 2013

NHLBI Division
DLD

Dataset(s) Last Updated
March 30, 2020

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

Subjects:

rosuvastatin: 379

placebo: 366

 

Age:
 

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

 
Sex:

 

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

 
Race:

 

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

 

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

Visits (Vials):

06/22/2022

  Plasma Urine Total
Day 0 2,490 2,663 5,153
Day 3 2,755 2,321 5,076
Day 6 2,072 1,661 3,733
Day 12 96 0 96
Unknown 6 8 14
Visits (Subjects):

06/22/2022

  Plasma
Total number of subjects Average volume (ml) per subject
Day 0 725 2.24
Day 3 649 2.88
Day 6 507 3.82
Day 12 25 6.10
Unknown 1 12.00

 

  Urine
Total number of subjects Average volume (ml) per subject
Day 0 691 5.95
Day 3 606 5.92
Day 6 429 6.03
Unknown 1 16.00

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Resources Available

Specimens and Study Datasets

Materials Available

Study Documents

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