Status:
COMPLETED
Hemodynamics and Extravascular Lung Water in Acute Lung Injury
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Pulsion Medical Systems
Oregon Clinical and Translational Research Institute
Conditions:
Acute Lung Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
The objective of this study is to conduct a randomized, controlled trial of a goal directed therapy designed to improve outcome in patients with acute lung injury (ALI). The investigators are comparin...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00624650
Start Date
February 1 2008
End Date
January 1 2011
Last Update
September 10 2019
Active Locations (3)
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1
Kaiser Permanente Sunnyside
Clackamas, Oregon, United States, 97015
2
Legacy Good Samaritan
Portland, Oregon, United States, 97210
3
Oregon Health and Science University
Portland, Oregon, United States, 97219