Please select the eligibility criteria that correspond to the clinical trial below.
Title: Modulation of Lung Injury Complicating Lung Resection
Brief Summary: The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.


Options:
A: Inclusion Criteria:

* Elective lung resection for cancer

Exclusion Criteria:

* Age less than 18 years
* Women of child-bearing age or potential
* Known allergy to N-acetylcysteine
* Oral steroid in the preceding 1 month
* N-acetylcysteine in the preceding 1 month
* Unable to receive standardised anaesthetic approach
B: Inclusion Criteria:

* Age ≥18 years old
* Patients must have acute onset of ARDS, as defined by the American-European Consensus Conference (AECC) criteria for ARDS: (i) having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.; (ii) bilateral infiltrates on frontal chest radiograph; (iii) absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure; (iv) severe hypoxemia (a PaO2/FIO2 \<200 mm Hg, regardless of FIO2 or positive end-expiratory pressure (PEEP)
* Be intubated and mechanically ventilated
* Have provided signed written informed consent from the patient or the patient's personal legal representative

Exclusion Criteria:

* Be a woman known to be pregnant or lactating
* Take part in another experimental treatment protocol (simultaneously)
* Brain death
* Terminal-stage cancer or other terminal disease
* Having do-not-resuscitate orders
* Being immune-compromised
* Receiving corticosteroids or immunosuppressive drugs
* Patients in whom more than 24 hours had elapsed after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.
* Have severe chronic obstructive pulmonary disease (COPD)
* Have congestive heart failure
C: Inclusion Criteria:

* PaO2/FiO2 levels less than or equal to 300
* Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
* Positive pressure ventilation through an endotracheal tube or tracheostomy
* No clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates; if measured, pulmonary arterial wedge pressure less than or equal to 18 mm Hg

Exclusion Criteria:

* Family / patient refuses
* Patient / surrogate unavailable
* Attending refuses
* Age younger than 18 years
* Severe sepsis and Acute Physiology and Chronic Health Evaluation (APACHE) II scores greater than 25 within 48 hours of onset of severe sepsis
* Greater than 72 hours since all inclusion criteria are met
* Neuromuscular disease that impairs ability to ventilate without assistance, such as C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré syndrome, myasthenia gravis, or kyphoscoliosis
* Pregnant
* Severe chronic respiratory disease
* Weighs more than 160 kg
* Burns to more than 70% of total body surface area
* Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
* Bone marrow transplant in the 5 years prior to study entry
* Not committed to full support
* Severe chronic liver disease, as determined by a Child-Pugh Score of 11 to 15
* Diffuse alveolar hemorrhage from vasculitis
* Participation in another experimental medication study within 30 days of study entry
* Patients who have already received APC therapy
* Active internal bleeding
* Hemorrhagic or ischemic stroke within 3 months of study entry
* Intracranial or intraspinal surgery or severe head trauma within 2 months of study entry
* Trauma with an increased risk of life-threatening bleeding
* Presence of an epidural catheter
* Intracranial neoplasm mass lesion or evidence of cerebral herniation
* High risk of intracranial hemorrhage, as determined by 1 of the following: 1) intracranial or spinal pathology which places individuals at risk for intracranial hemorrhage (e.g., arterio-venous malformation or previous intracranial bleeding events, not including meningitis); 2) acute change in neurological status with focal neurological findings; 3) documented intracranial hypertension by lumbar puncture or imaging; or 4) seizures in which there is a clinical suspicion of intracranial hemorrhage
* Known bleeding diathesis
* Concurrent therapeutic heparin (greater than 14 units/kg/hr)
* Platelet count less than 30,000 x 106/L, even if the platelet count is increased after transfusions
* Prothrombin time greater than 3.0 INR
* Gastrointestinal bleeding within 6 weeks of study entry
* Concurrent need for systemic anticoagulation with therapeutic unfractionated heparin or low molecular weight heparin during the study drug infusion
* Concurrent administration of an anticoagulant (other than subcutaneous heparin for prophylaxis)
* Concurrent need for platelet glycoprotein Iib/IIIa antagonists or any other antiplatelet agents (patients taking aspirin or other antiplatelet agents at study entry are eligible if medication can be discontinued during study drug infusion)
* Surgery within 30 days of study entry and single organ failure
D: Inclusion Criteria:

* Patients intubated and on mechanical ventilation
* Patients with Acute Lung Injury defined as (a, b, c and d are all applicable): a: PaO2/FiO2 \< or equal to 300 mmHg (40.0 kPa) (regardless of PEEP level), b: Acute onset, c: Pulmonary artery wedge pressure \< or equal to 18 mmHg when measured or no clinical evidence of left atrial hypertension, d: Bilateral infiltrates seen on frontal chest radiograph
* Less than 60 hours from onset of the present period of mechanical ventilation to 1st instillation
* Expected to continue on mechanical ventilation for more than 24 hours
* 18 years of age or older
* Following receipt of verbal and written information about the trial, the patient or legally acceptable representative must provide signed and dated informed consent before any trial related activity is carried out

Exclusion Criteria:

* Current diagnosis of acute bronchial asthma attack
* History of or clinical suspicion of lung fibrosis
* Current diagnosis of suspected pulmonary thrombo-embolism
* Patients on daily medication for chronic obstructive pulmonary disease at time of admission to ICU
* Patients who have received mechanical ventilation for more than 48 hours continuously within 1 month prior to the present period of mechanical ventilation
* Patients with pneumonectomy or lobectomy
* Patients with untreated pneumothorax at time of instillation
* Patients having tracheostomy at time of instillation
* Patients who have had surgical procedures under general anaesthesia performed within 6 hours prior to inclusion blood gas sample
* Patients having mean arterial blood pressure \< 50 mmHg in spite of adequate fluid administration and/or vasoactive drugs at time of instillation
* Patients having PaO2 \< 75 mmHg with a FiO2 = 1.0 not responding to adjustment of PEEP at time of instillation
* Glasgow Coma Score \< or equal to 10 before sedation or major findings on CT/MR scan of the head such as: brain oedema, acute space occupying lesion, other acute lesions with bleeding or mass effect (patients with minor lesion which do not require further diagnostics or monitoring can be included)
* Patients with life expectancy less than 3 months due to primary disease assessed by the attending physician (e.g., end-stage cancer, AIDS or generally poor health)
* Known or suspected hypersensitivity to constituents(s) of the investigational product
* Patients who have received treatment with any investigational drug within the previous 4 weeks
* Current participation in any other interventional clinical trial until day 29 of the trial
* Patients previously randomised in this trial
* Patients known or suspected of not being able to comply with a study protocol (e.g., due to alcoholism, drug dependency or psychotic state)
* Females of childbearing potential who have a positive pregnancy test or who are breast feeding
* Patients suffering from highly infectious diseases where trial related procedures could pose a safety risk for the staff (e.g., SARS)

Answer: A