Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295269
Status:
COMPLETED
Last Update Posted:
2006-05-09
First Post:
2006-02-21
Brief Title:
Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Late Steroid Rescue Study LaSRS The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome ARDS as well as those at risk of developing ARDS
Detailed Description:
BACKGROUND
ARDS affects approximately 150000 people in the United States each year Despite twenty years of research into the mechanisms that cause this syndrome and numerous developments in the technology of mechanical ventilation the mortality rate has remained greater than 50 percent In addition to the tragic loss of human life this condition poses a cost to society because these patients spend an average of two weeks in intensive care units and require multiple high tech procedures Because of the overwhelming nature of the lung injury once it is established prevention appears to be the most effective strategy for improving the outlook for those with ARDS
Basic research has identified numerous inflammatory pathways that are associated with the development of ARDS Agents that block these mediators prolong survival in animals with lung injury and a few of them have been tested in human patients Because of the large number of putative mediators and the variety of ways that their action can be blocked the possibility for new drug development is almost infinite This is an exciting prospect since it envisions the first effective pharmacologic treatment for ARDS However preliminary clinical studies have shown conflicting results and there is an urgent need for a mechanism to efficiently and effectively test new drugs in ARDS Treatment studies in patients with ARDS are difficult to perform for three reasons First the complicated clinical picture makes it difficult to accumulate a large number of comparable patients in any one center Secondly there is no agreement on the optimal supportive care of these critically ill patients Finally many of the patients meeting study criteria will not be enrolled in study protocols because of the acute nature of the disease process For these reasons therapeutic trials in ARDS require multicenter cooperation
DESIGN NARRATIVE
This study compared the effect of corticosteroids with placebo in the management of late-phase greater than seven days ARDS The study determined if the administration of the corticosteroid methylprednisolone sodium succinate in severe ARDS that was either stable or worsening after seven days would reduce mortality and morbidity The primary endpoint was mortality at 60 days Secondary endpoints included ventilator-free days and organ failure-free days LaSRS was designed to include 400 patients and began recruiting in the Spring of 1997 In October 1999 the data and safety monitoring board DSMB reduced the recruitment target number to 200 patients because the eligible patients were fewer than anticipated
ARDS affects approximately 150000 people in the United States each year Despite twenty years of research into the mechanisms that cause this syndrome and numerous developments in the technology of mechanical ventilation the mortality rate has remained greater than 50 percent In addition to the tragic loss of human life this condition poses a cost to society because these patients spend an average of two weeks in intensive care units and require multiple high tech procedures Because of the overwhelming nature of the lung injury once it is established prevention appears to be the most effective strategy for improving the outlook for those with ARDS
Basic research has identified numerous inflammatory pathways that are associated with the development of ARDS Agents that block these mediators prolong survival in animals with lung injury and a few of them have been tested in human patients Because of the large number of putative mediators and the variety of ways that their action can be blocked the possibility for new drug development is almost infinite This is an exciting prospect since it envisions the first effective pharmacologic treatment for ARDS However preliminary clinical studies have shown conflicting results and there is an urgent need for a mechanism to efficiently and effectively test new drugs in ARDS Treatment studies in patients with ARDS are difficult to perform for three reasons First the complicated clinical picture makes it difficult to accumulate a large number of comparable patients in any one center Secondly there is no agreement on the optimal supportive care of these critically ill patients Finally many of the patients meeting study criteria will not be enrolled in study protocols because of the acute nature of the disease process For these reasons therapeutic trials in ARDS require multicenter cooperation
DESIGN NARRATIVE
This study compared the effect of corticosteroids with placebo in the management of late-phase greater than seven days ARDS The study determined if the administration of the corticosteroid methylprednisolone sodium succinate in severe ARDS that was either stable or worsening after seven days would reduce mortality and morbidity The primary endpoint was mortality at 60 days Secondary endpoints included ventilator-free days and organ failure-free days LaSRS was designed to include 400 patients and began recruiting in the Spring of 1997 In October 1999 the data and safety monitoring board DSMB reduced the recruitment target number to 200 patients because the eligible patients were fewer than anticipated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01 HR46064 | None | None | None |
| N01 HR46054 | None | None | None |
| N01 HR46055 | None | None | None |
| N01 HR46056 | None | None | None |
| N01 HR46057 | None | None | None |
| N01 HR46058 | None | None | None |
| N01 HR46059 | None | None | None |
| N01 HR46060 | None | None | None |
| N01 HR46061 | None | None | None |
| N01 HR46062 | None | None | None |
| N01 HR46063 | None | None | None |