Please select the eligibility criteria that correspond to the clinical trial below.
Title: Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Diagnosed with ARDS or has risk factors for ARDS; individuals will be considered at risk if they are critically ill and have trauma, sepsis, shock, pneumonia, inhalation injury, drug overdose, pancreatitis, or hypertransfusion
* Onset of ARDS must be between 7 and 28 days prior to study entry
* Since ARDS onset, bilateral infiltrates must have persisted and participants must have required continuous mechanical ventilation
B: Inclusion Criteria:

Acute onset of illness with:

* PaO2/FiO2 ratio of less than 300 (ALI) or PaO2/FiO2 ratio of less than 200 (ARDS)
* Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
* Requirement for positive pressure ventilation via an endotracheal tube
* No clinical evidence of left atrial hypertension (pulmonary arterial wedge pressure measure up to 18 mm Hg)
* First three criteria must occur together within a 24-hour interval

Exclusion criteria:

* Greater than 7 days elapsed following institution of mechanical ventilation
* Pregnancy
* Chronic respiratory failure as defined by any of the following: 1) FEV1 less than 20 ml/kg of PBW; or 2) FEV1/FVC less than 50%
* Chronic hypercapnia or hypoxemia
* Hospitalization within the past 6 months for acute respiratory failure
* Chronic home use of oxygen or mechanical ventilation
* Left ventricular failure as defined by New York Heart Association (NYHA) class IV status
* Neutropenia (absolute neutrophil count less than 1000 cells/mm3)
* History of hematological malignancy or bone marrow transplant
* Entry into other intervention clinical trials
* Decision of the patient or attending physician to forego aggressive care
* Expected survival rate of less than 6 months (based solely on pre-existing medical problems \[i.e., poorly controlled neoplasm or other end-stage disease\])
* AIDS or known history of HIV infection
* Prednisone (or equivalent) therapy greater than or equal to 20 mg/day for a period of not less than 2 months with treatment continuing within 3 weeks prior to screening
* Cytotoxic therapy within 3 weeks of screening
* Morbid obesity defined as greater than 1 kg/c, body weight
* At risk for increased intracranial pressure that may result from permissive hypercapnia or in whom permissive hypercapnia may be otherwise contraindicated
* Neuromuscular disease that would potentially impact ability to wean from mechanical ventilation
* Receiving extracorporeal membrane oxygenation when meeting screening criteria
C: Inclusion Criteria:

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

Exclusion Criteria:

1. Pre-existing lung disease
2. coma
3. limited therapeutic goals (do not resuscitate, etc.)
4. failure of another vital organ
D: Inclusion Criteria:

* Must meet the following three criteria within a 24-hour period:

  1. Acute onset of PaO2/FiO2 less than or equal to 300 (adjustments made for altitude where appropriate)
  2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
  3. Requirement for positive pressure ventilation via endotracheal tube
* No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates

Exclusion Criteria:

* Greater than 48 hours since all inclusion criteria are met
* Neuromuscular disease that impairs ability to ventilate without assistance, (e.g., cervical spinal cord injury at level C5 or higher spinal cord injury amyotrophic lateral sclerosis, Guillain-Barré syndrome or myasthenia gravis)
* Pregnant or breast-feeding
* Severe chronic respiratory disease (i.e., chronic hypercapnia \[PaCO2 greater than 45 mmHg\], chronic hypoxemia \[PaO2 less than 55 mmHg on FiO2 = 0.21\], hospitalization within the last 6 months for respiratory failure \[PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mmHg on 0.21 FiO2\], secondary polycythemia, severe pulmonary hypertension \[mean PAP (pulmonary artery pressure) greater than 40 mmHg\], or ventilator dependency)
* Burns over greater than 40% of total body surface area
* Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
* Allogeneic bone marrow transplant within the 5 years prior to study entry
* Participant, surrogate, or physician is not committed to full support (Exception: a participant will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
* Severe chronic liver disease (Child-Pugh score of 11-15)
* Diffuse alveolar hemorrhage from vasculitis
* Morbid obesity (greater than 1kg/cm body weight.)
* Unwillingness or inability to utilize the ARDS network 6 ml / kg Predicted Body Weight (PBW) ventilation protocol
* Moribund participant and is not expected to survive 24 hours
* No intent to obtain central venous access for monitoring intravascular pressures
* Contraindication to aerosolized albuterol (see Appendix A.8 of the protocol for more information)
* Daily use (prior to study hospitalization) of inhaled beta agonist, corticosteroid, or oral leukotriene modifier
* Unwillingness of primary physician to discontinue inpatient beta agonist use
* Acute myocardial infarction or acute coronary syndrome within 30 days of study entry
* Severe congestive heart failure (see Appendix A5 of the protocol for more information)
* Participation in other experimental medication trial within 30 days of study entry with the exception of the ARDSNet pharmaconutrient nutrition trial (OMEGA)
* Heart rate greater than 85% of maximal predicted heart rate (MHR85) as calculated by MHR85 = 85% x (220-age)
* Currently receiving high frequency ventilation

Answer: C