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

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/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
https://www.ncbi.nlm.nih.gov/pubmed/16625008
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. Section 3 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.