Skip to Main Content
U.S. Department of Health & Human Services » National Institutes of Health
National Heart, Lung, and Blood Institute
Login | Register

Biologic Specimen and Data Repository Information Coordinating Center

  • Home (current)
  • About BioLINCC
    • About Us
    • FAQ
    • Contact Us
    • Glossary
  • Biospecimen and Data Resources
    • Overview
    • Studies
    • Teaching Datasets - Public Use Datasets
    • Renew Existing Data Use Agreement
    • Publications
    • Funding Opportunities
    • Non-BioLINCC Resources
    • Covid-19 Resources
  • Procedures and Forms
    • BioLINCC Handbook
    • Form Templates
    • Agreement Templates
  • Build/Submit New Collection
    • NHLBI Biorepository Guide
    • Submit Datasets
    • Submit Biospecimens and Datasets
Home > Studies > ARDSNet-SAILS > Catalog

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

Basic Study Information

Name

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

Accession Number

HLB01201414a

Acronym

ARDSNet-SAILS

Related studies

BSI Study IDs

AR10

AR12

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

http://www.ardsnet.org/

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT00979121
Study type

Clinical Trial

Collection Type

Open BioLINCC Study

Cohort type

Adult

Interventions

Drug: RosuvastatinDrug: Placebo

Study Open Date (Data)

2014-12-16

Study Open Date (Specimens)

2014-12-16

Date materials available

2014-12-05

Last updated

None

Study period

2010 - 2013

Study Contacts
NHLBI Division

DLD

Classification

Lung

HIV study classification

non-HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

0

# of Returned Specimens

0

Primary Publication URLs
http://www.ncbi.nlm.nih.gov/pubmed/24835849

Study 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.

Additional Study Information

Conditions

ALI
ARDS
Acute Lung Injury
Lung Diseases
Sepsis

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.

Disease classification

Publications

Mat types

Plasma
Urine

Study Population

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    rosuvastatin: 379

    placebo: 366

     


    Last Modified: June 22, 2022, 11:06 a.m.
  • 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

     

    Last Modified: June 22, 2022, 11:06 a.m.
  • 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

     

    Last Modified: June 22, 2022, 11:06 a.m.
  • 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

     

    Last Modified: June 22, 2022, 11:06 a.m.

Available Biospecimens

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

  • Material Types

    Last Modified: Aug. 28, 2015, 11:03 a.m.
  • General Freeze/Thaw Status

    Last Modified: Aug. 28, 2015, 11:03 a.m.
  • 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

    Last Modified: June 22, 2022, 11:06 a.m.
  • 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

    Last Modified: June 22, 2022, 11:06 a.m.
  • About Us
  • FAQ
  • Glossary
  • Contact
  • Privacy Policy
  • Accessibility
  • FOIA
  • HHS Vulnerability Disclosure

  • U.S. Department of Health & Human Services
  • National Institutes of Health
  • National Heart, Lung, and Blood Institute
  • USA.gov
NIH… Turning Discovery Into Health®