KL₄Surfactant Treatment in Patients With ARDS

• Status: Terminated
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Windtree Therapeutics
• Treatments: Pulmonary Surfactants

Criteria

Inclusion Criteria:

• Intubated and required mechanical ventilation support

• Met the criteria for ARDS

• Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 200 mmHg and ≥ 60 mmHg within 60 minutes before randomization

• Mean blood pressure was ≥ 60 mmHg immediately before randomization

Exclusion Criteria:

• Had ARDS due solely to a major trauma

• Was currently participating in another clinical trial or received an experimental drug or device within the previous month

• A woman of childbearing age, unless pregnancy was excluded by a negative urine hCG test or if the subject was surgically incapable of childbearing

• Had a previous episode of ARDS that resolved and then recurred during the current hospitalization

• Had a disease that was sufficiently advanced, in the best judgment of the Principal Investigator, to markedly limit life expectancy to < 6 months

• Was known to have AIDS or symptomatic HIV (CD4 counts <500). Subjects with asymptomatic HIV were not excluded

• Received chemotherapy or radiation within the previous 90 days

• Received an organ transplant other than corneal transplants

• Received, or was currently receiving, immunosuppression therapy within the last 6 months

• Had severe neurological damage or the presence of a disease that was likely to significantly prevent weaning from the ventilator

• Had a best Glasgow Coma Score (GCS) of ≤ 8 or an intracranial pressure ≥ 20 cm H2O prior to the institution of sedatives or paralysis