Clinical trial NCT00624650: Hemodynamics and Extravascular Lung Water in Acute Lung Injury
Official title: Hemodynamics and Extravascular Lung Water in Acute Lung Injury: A Prospective Randomized Controlled Multicentered Trial of Goal Directed Treatment of EVLW Versus Standard Management for the Treatment of Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lung Injury
Keywords: Acute Lung Injury
Extravascular Lung Water
Acute Respiratory Distress Syndrome
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Pulsion Medical Systems
name: Oregon Clinical and Translational Research Institute
First posted: 2008-02-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 comparing two algorithmic approaches in managing patients with ALI - one, the control arm, attempts to reduce the amount of fluid in the lung in patients with ALI by diuresis based on central venous pressure and urine output, the other the treatment arm attempting to reduce lung water by directing therapy to measured lung water and using more sensitive indicators of preload status than CVP. The protocol uses measured extravascular lung water (EVLW) to direct diuresis and appropriate fluid restriction in a goal directed fashion in order to lower EVLW towards the normal range.

Eligibility criteria: Inclusion Criteria:

Acute onset of:

1. PaO2/FiO2 less than or equal to 300.
2. Bilateral infiltrates consistent with pulmonary edema on the frontal chest radiograph.
3. Requirement for positive pressure ventilation through an endotracheal tube or tracheostomy.
4. 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 Criteria:

1. Age younger than 18 years old.
2. Greater than 24 hours since all inclusion criteria first met.
3. 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).
4. Pregnancy (negative pregnancy test required for women of child-bearing potential).
5. Severe chronic respiratory disease (see Appendix I.C).
6. Severe Chronic Liver Disease (Child-Pugh 11 - 15, see Appendix I.E)
7. Weight \> 160 kg.
8. Burns greater than 70% total body surface area.
9. Malignancy or other irreversible disease or conditions for which 6-month mortality is estimated to be greater than 50 % (see Appendix I.A).
10. Known cardiac or vascular aneurysm.
11. Contraindications to femoral arterial puncture - platelets \< 30, bilateral femoral arterial grafts, INR \> 3.0.
12. Not committed to full support.
13. Participation in other experimental medication trial within 30 days.
14. Allergy to intravenous lasix or any components of its carrier.
15. History of severe CHF - NYHA class ≥ III, previously documented EF \< 30%.
16. Diffuse alveolar hemorrhage.
17. 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).

Primary outcomes:
measure: The Primary Efficacy Variable Will be the Total Reduction in Measured Lung Water
timeFrame: The first seven days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Clackamas
country: United States
facility: Kaiser Permanente Sunnyside
state: Oregon
city: Portland
country: United States
facility: Legacy Good Samaritan
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Charles Phillips, M.D.
role: PRINCIPAL_INVESTIGATOR
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