Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosed with ARDS or has risk factors for ARDS; individuals will be considered at risk if they are critically ill and have trauma, sepsis, shock, pneumonia, inhalation injury, drug overdose, pancreatitis, or hypertransfusion - Onset of ARDS must be between 7 and 28 days prior to study entry - Since ARDS onset, bilateral infiltrates must have persisted and participants must have required continuous mechanical ventilation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
Steinberg KP, Hudson LD, Goodman RB, Hough CL, Lanken PN, Hyzy R, Thompson BT, Ancukiewicz M; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Efficacy and safety of corticosteroids for persiste — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality rates (measured at time of hospital discharge or 60 days after study entry) | |||
Secondary | Number of ventilator-free days (measured at 28 days following study entry) | |||
Secondary | Number of organ failure-free days (measured at 28 days following study entry) | |||
Secondary | Reduction in markers of ongoing inflammation and fibroproliferation (measured at 7 days following study entry) |
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