Trial | NCT00682500  Report issue

Title

Calfactant for Direct Acute Respiratory Distress Syndrome
Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    calfactant ...

  • Study Participants

    332
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.
Study Started
May 31
2008
Primary Completion
Dec 31
2010
Study Completion
Feb 28
2011
Last Update
Jul 24
2012
Estimate

Drug Calfactant

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.

  • Other names: PneumoSurf

Drug Room Air (placebo)

Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met

  • Other names: placebo

1 Experimental

Calfactant treatment

2 Placebo Comparator

Criteria 

Inclusion Criteria:

Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
Less than 48 hours of mechanical ventilation
Informed consent

Exclusion Criteria:

Pre-existing lung disease
coma
limited therapeutic goals (do not resuscitate, etc.)
failure of another vital organ
No Results Posted