KL₄Surfactant Treatment in Patients With ARDS
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: A.1 Lucinactant; B.3 SoC; A.2 Lucinactant; A.3 Lucinactant; A.4 Lucinactant; B.1 Lucinactant; B.2 Lucinactant
Intervention description: 3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL; Standard ARDS management and ICU care; 3 30 mL aliquots at a concentration of 10 mg/mL each; 2 50 mL aliquots at concentrations of 10 and 20 mg/mL; 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed; 2 50 mL aliquots at concentrations of 10 and 20 mg/mL; 2 50 mL aliquots at concentrations of 10 and 20 mg/mL, with bolus re-treatment allowed
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No

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).
    

Eligibility 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