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
Date Prepared
October 13, 2008
Last Updated
August 24, 2006
Clinical Trial URLs
https://clinicaltrials.gov/ct2/sho…
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubme…
Study Website
http://www.ardsnet.org/
Related Studies
N/A
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.
Subjects
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
Methylprednisolone: 89
Placebo: 91
|
|
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 |
|
|
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 |
|
|
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
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 DatasetsMaterials Available
- BAL Slides
- Bronchial Lavage
- Plasma
- More Details
Study Documents
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