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

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
http://clinicaltrials.gov/ct2/sh...

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

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

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

Study Population

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

Available Biospecimens

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):

9/21/2015

	Plasma	LEUKOCYTES	BRONCHIAL LAVAGE	Total
Day 0	124	267	1,934	2,325
Day 7	111	211	1,383	1,705

Visits (Subjects):

9/21/2015

	Plasma	BRONCHIAL LAVAGE
Day 0	23	6.27	86	29.34
Day 7	21	5.30	64	28.67

Plasma

BRONCHIAL LAVAGE

Total number

of subjects

Average volume (ml)

per subject

Total number

of subjects

Average volume (ml)

per subject

Day 0

6.27

29.34

Day 7

5.30

28.67

	LEUKOCYTES
	Total number of subjects	Average vials per subject
Day 0	67	3.99
Day 7	52	4.06

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Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (9)

Materials Available

Bronchial Lavage
Plasma
BAL Slides

More Details

Study Documents

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