Acute Respiratory Distress Network (ARDSNet) Study 02 Late Steroid Rescue Study (LaSRS) - Catalog

  • Name

    Acute Respiratory Distress Network (ARDSNet) Study 02 Late Steroid Rescue Study (LaSRS)

  • Accession Number

    HLB00660808a

  • Acronym

    ARDSNet-LaSRS

  • Related studies
  • BSI Study IDs

    AR2

  • Is public use dataset

    False

  • Keywords
  • Ingestion Status
    Released
  • 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
    NCT00000579
  • Study type
    Clinical Trial
  • Collection Type
    Open BioLINCC Study
  • Cohort type
    Both
  • Interventions

    Procedure: Low Tidal Volume VentilationProcedure: Positive End-Expiratory PressureDrug: LysofyllineDrug: MethylprednisoloneDrug: KetoconazoleProcedure: Fluid ManagementProcedure: Pulmonary Artery Catheter

  • Study Open Date (Data)

    2009-10-01

  • Study Open Date (Specimens)

    2010-04-09

  • Date materials available

    2008-10-13

  • Last updated

    2006-08-24

  • Study period

    1997-2003

  • Study Contacts
  • NHLBI Division

    DLD

  • Classification
    Lung
  • HIV study classification
    non-HIV
  • COVID study classification
    non-COVID
  • Pre-Website # of Specimens Shipped

    4183

  • # of Returned Specimens

    0

  • Primary Publication URLs
    16625008
  • Commercial use data restrictions
    No
  • Data restrictions based on area of research
    No
  • Commercial use specimen restrictions
    No
  • Non-genetic use specimen restrictions based on area of use
    No
  • Genetic use of specimens allowed?
    Yes, For Some Specimens
  • Genetic use area of research restrictions
    No
  • Specific Consent Restrictions
  • Conditions
    ALI
    ARDS
    Acute Lung Injury
    Lung Diseases
    Respiratory Distress Syndrome, Adult
  • Objectives

    Since previous reports suggested that corticosteroids may improve survival, this project was developed as a multicenter, randomized controlled trial of corticosteroids in patients with persistent ARDS.

  • Background

    Persistent acute respiratory distress syndrome (ARDS) is characterized by excessive fibroproliferation, ongoing inflammation, prolonged mechanical ventilation, and a substantial risk of death.

  • Participants

    180 randomly assigned patients with ARDS of at least seven days duration received either methylprednisolone or placebo in a double-blind fashion. The primary end point was mortality at 60 days.

  • Design
  • Conclusions

    The results do not support the routine use of methylprednisolone for persistent ARDS despite the improvement in cardiopulmonary physiology. In addition, starting methylprednisolone therapy more than two weeks after the onset of ARDS may increase the risk of death. (NEJM April 20, 2006; Vol 354, No. 16, pp 1671-84)

  • Disease classification
  • Publications
  • Mat types
    BAL Slides
    Bronchial Lavage
    Plasma
  • Network
    Acute Respiratory Distress Network (ARDSNet)

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

  • Subjects

    Methylprednisolone: 89

    Placebo: 91


    Last Modified: July 28, 2014, 4:59 p.m.
  • Age

     

    methylprednisolone

    placebo

    All

    N

    %

    N

    %

    N

    %

    16-20

    5

    5.62

    3

    3.30

    8

    4.44

    21-25

    7

    7.87

    5

    5.49

    12

    6.67

    26-30

    3

    3.37

    5

    5.49

    8

    4.44

    31-35

    9

    10.11

    6

    6.59

    15

    8.33

    36-40

    10

    11.24

    12

    13.19

    22

    12.22

    41-45

    11

    12.36

    8

    8.79

    19

    10.56

    46-50

    5

    5.62

    9

    9.89

    14

    7.78

    51-55

    3

    3.37

    13

    14.29

    16

    8.89

    56-60

    9

    10.11

    8

    8.79

    17

    9.44

    61-65

    6

    6.74

    7

    7.69

    13

    7.22

    66-70

    7

    7.87

    4

    4.40

    11

    6.11

    71-75

    4

    4.49

    2

    2.20

    6

    3.33

    76-80

    6

    6.74

    8

    8.79

    14

    7.78

    81-85

    3

    3.37

    1

    1.10

    4

    2.22

    86-90

    1

    1.12

    .

    .

    1

    0.56
     

    Last Modified: Aug. 21, 2015, 3:53 p.m.
  • Sex
     

     

    methylprednisolone

    placebo

    All

    N

    %

    N

    %

    N

    %

    Female

    36

    40.45

    53

    58.24

    89

    49.44

    Male

    53

    59.55

    38

    41.76

    91

    50.56
     

    Last Modified: Aug. 21, 2015, 3:53 p.m.
  • Race

     

    methylprednisolone

    placebo

    All

    N

    %

    N

    %

    N

    %

    White non-Hispanic

    59

    66.29

    72

    79.12

    131

    72.78

    Black non-Hispanic

    19

    21.35

    9

    9.89

    28

    15.56

    Other

    11

    12.36

    10

    10.99

    21

    11.67
     

    Last Modified: Aug. 21, 2015, 3:53 p.m.

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. PDF Section 3.0 of the BioLINCC Handbook describes the components of the review process.

  • Material Types

    Last Modified: Nov. 30, 2015, 1:14 p.m.
  • General Freeze/Thaw Status
  • Visits (Vials)

    03/08/2021

      Plasma Bronchial Lavage BAL Slides Total
    Day 0 85 1,852 330 2,267
    Day 7 75 1,351 221 1,647

     

    Last Modified: March 8, 2021, 4:29 p.m.
  • Visits (Subjects)

    03/08/2021

      Plasma
    Total number of subjects Average volume (ml) per subject
    Day 0 14 6.61
    Day 7 13 5.78
     
      Bronchial Lavage
    Total number of subjects Average volume (ml) per subject
    Day 0 86 28.42
    Day 7 64 28.26
     
      BAL Slides
    Total number of subjects Average vials per subject
    Day 0 74 4.46
    Day 7 54 4.09

     

    Last Modified: March 8, 2021, 4:29 p.m.