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

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Accession Number
HLB00660808a

Study Type
Clinical Trial

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

Study Period
1997-2003

NHLBI Division
DLD

Dataset(s) Last Updated
August 5, 2024

Clinical Trial URLs
NCT00000579

Primary Publication URLs
16625008

Consent

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

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.

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)

Additional Details

Subjects:

Placebo: 91

Methylprednisolone: 89

Age:

 

Placebo

Methylprednisolone

Total Subjects

< 30

11

14

25

30-39

16

19

35

40-49

18

16

34

50-59

23

13

36

60-69

11

11

22

70+

12

16

28

Sex:

 

Placebo

Methylprednisolone

Total Subjects

Female

53

36

89

Male

38

53

91

Race:

 

Placebo

Methylprednisolone

Total Subjects

White non-Hispanic

72

59

131

Black non-Hispanic

9

19

28

Other

10

11

21

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. The BioLINCC Users Guide describes the components of the review process

Material Types:

Plasma, Bronchoalveolar Lavage (BAL), BAL Slide

General Freeze/Thaw Status:

Plasma: Majority unthawed

BAL: Majority 1 thaw

BAL Slides: Unthawed

Visits (Vials):

01/06/2026

 

Plasma

Bronchoalveolar Lavage (BAL)

BAL Slide

Total Vials

Day 0

85

1,837

330

2,252

Day 7

75

1,351

221

1,647

Visits (Subjects):

01/06/2026

 

 

Plasma

Total number of subjects

Average volume (mL) per subject

Day 0

14

5.47

Day 7

13

5.78

 

 

Bronchoalveolar Lavage (BAL)

Total number of subjects

Average volume (uL) per subject

Day 0

86

28.34

Day 7

64

28.26

 

 

BAL Slide

Total number of subjects

Average vials per subject

Day 0

74

4.46

Day 7

54

4.09

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Resources Available

Specimens and Study Datasets

Materials Available

Study Documents

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