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ARDSNet Clinical Trials (KARMA, LARMA, LaSRS)
NCT00000579Phase 3
Key facts
- Status
- Completed
- Start
- Sep 1994
- Countries
- 2
- Sponsor
- National Heart, Lung, and Blood Institute
- Modality
- Orthosteric Ligands
- Conditions
- acute respiratory distress syndrome (ARDS)acute lung injury (ALI)
01
Overview
Phase 3, randomised, double-blind trial of ketoconazole, lisofylline and methylprednisolone in acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) (8 arms), sponsored by National Heart, Lung, and Blood Institute. Primary endpoint: Mortality at 60 days. Started Sep 1994; status: completed.
02
Design
8 arms- Study design
- RandomizedDouble-blind
Ketoconazole
Ketoconazole treatment
Placebo (Ketoconazole)
Placebo for Ketoconazole
Lisofylline
Lisofylline treatment
Placebo (Lisofylline)
Placebo for Lisofylline
Methylprednisolone
Methylprednisolone treatment
Placebo (Methylprednisolone)
Placebo for Methylprednisolone
2 more in the full profile.
03
Who it enrols
Patients 13 years or older with ARDS or risk factors for ARDS (critically ill with trauma, sepsis, shock, pneumonia, inhalation injury, drug overdose, pancreatitis, or hypertransfusion).
04
Endpoints
Primary
Mortality
Secondary
Ventilator-free days
Organ failure-free days
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