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

Study Website
http://www.ardsnet.org/

Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT00000579

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

Methylprednisolone: 89

Placebo: 91

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
 
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
 
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
 

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):

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

 
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

 

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Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (11)

Materials Available

Study Documents

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