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Expected mortality rates in placebo and treatment groups lower than predicted
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This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.
Recruitment limited to direct adult respiratory distress syndrome patients who have been intubated <48 hours. Origin of ARDS must be infectious pneumonia, aspiration of stomach contents, near drowning, smoke inhalation without pulmonary burn, inhaled industrial gas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Calfactant treatment |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calfactant | Drug | Intratracheal Instillation of 0.5 mL/cm of height of 60 mg/mL suspension in two aliquots at study entry. Repeat dosing 12 hours later if criteria are met. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Willson, MD | Univeristy of Virginia Health Sciences Center | Study Chair |
| Jonathon Truwit, MD | University of Virginia Health Sciences Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | United States | |||
| Florida Hospital and Florida Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25855884 | Derived | Willson DF, Truwit JD, Conaway MR, Traul CS, Egan EE. The Adult Calfactant in Acute Respiratory Distress Syndrome Trial. Chest. 2015 Aug;148(2):356-364. doi: 10.1378/chest.14-1139. |
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|
| Room Air (placebo) | Drug | Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met |
|
|
| Orlando |
| Florida |
| United States |
| Northwestern University-Chicago | Chicago | Illinois | United States |
| West Suburban Hospital Medical Center | Oak Park | Illinois | United States |
| Peoria Pulmonary Associates/OSF St. Francis Hospital | Peoria | Illinois | United States |
| Clarian Health, Inc/Methodist Hospital | Indianapolis | Indiana | United States |
| University of Iowa | Iowa City | Iowa | United States |
| Creighton University | Omaha | Nebraska | 68131 | United States |
| Omaha Children's Hospital | Omaha | Nebraska | 68198 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States |
| Columbia Medical Center--Pediatrics | New York | New York | United States |
| The Oregon Clinic | Portland | Oregon | United States |
| Penn State University | Hershey | Pennsylvania | United States |
| Baylor College of Medicine/Texas Children's Hospital | Houston | Texas | United States |
| Uthscsa/Stvah | San Antonio | Texas | United States |
| University of Virginia Health Science Center | Charlottesville | Virginia | 22908 | United States |
| INOVA Fairfax Hospital | Fairfax | Virginia | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | United States |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Royal Columbian Hospital | New Westminster | British Columbia | Canada |
| British Columbia Children's Hospital | Vancouver | British Columbia | Canada |
| Surrey Memorial Hospital | Vancouver | British Columbia | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| Kingston General Hospital | Kingston | Ontario | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Ottawa Hospital | Ottawa | Ontario | Canada |
| Haemek Medical Center | Jerusalem | Israel |
| Rabin Medical Center | Jerusalem | Israel |
| Auckland City Hospital | Auckland | Auckland | New Zealand |
| Starship Children's Hospital | Auckland | New Zealand | New Zealand |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D011014 | Pneumonia |
| D004332 | Drowning |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C117342 | calfactant |
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