Hemodynamics and Extravascular Lung Water in Acute Lung Injury

Completed · Phase 2

Conditions studied: Acute Lung Injury

In brief

The purpose of this study is to test a treatment that tries to reduce the amount of fluid in the lungs of subjects with acute lung injury to see if this is helpful.

Key facts

Study ID

NCT00624650

Run by

Oregon Health and Science University

People needed

33

Starts

2008-02-01

Expected to finish

2011-01-01

Last updated by the study team

2019-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute onset of:
• PaO2/FiO2 less than or equal to 300.
• Bilateral infiltrates consistent with pulmonary edema on the frontal chest radiograph.
• Requirement for 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 mmHg.

You may not qualify if…

• Age younger than 18 years old.
• Greater than 24 hours since all inclusion criteria first 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 (see Appendix I.A).
• Pregnancy (negative pregnancy test required for women of child-bearing potential).
• Severe chronic respiratory disease (see Appendix I.C).
• Severe Chronic Liver Disease (Child-Pugh 11 - 15, see Appendix I.E)
• Weight > 160 kg.
• Burns greater than 70% total body surface area.
• Malignancy or other irreversible disease or conditions for which 6-month mortality is estimated to be greater than 50 % (see Appendix I.A).
• Known cardiac or vascular aneurysm.
• Contraindications to femoral arterial puncture - platelets < 30, bilateral femoral arterial grafts, INR > 3.0.
• Not committed to full support.
• Participation in other experimental medication trial within 30 days.
• Allergy to intravenous lasix or any components of its carrier.
• History of severe CHF - NYHA class ≥ III, previously documented EF < 30%.
• Diffuse alveolar hemorrhage.
• Presence of reactive airway disease (active will be defined based on recent frequency and amounts of MDI's use and steroids to control the disease).

Where it is running

• Kaiser Permanente Sunnyside — Clackamas, Oregon, United States
• Legacy Good Samaritan — Portland, Oregon, United States
• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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