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Phase 2 N=33 Randomized Single-blind Treatment

Hemodynamics and Extravascular Lung Water in Acute Lung Injury

Acute Lung Injury

Enrolled (actual)
33
Serious AEs
21.2%
Results posted
Sep 2019
Primary outcome: Primary: The Primary Efficacy Variable Will be the Total Reduction in Measured Lung Water

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Diuresis (furosemide) part I (Drug); Fluid Bolus (crystalloid or albumin) (Other); Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine) (Drug); Dobutamine (Drug); Concentrate all drips and nutrition (Other); Diuresis (furosemide) part II (Drug); Dialysis (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Oregon Health and Science University
Primary completion
Jan 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
The Primary Efficacy Variable Will be the Total Reduction in Measured Lung Water

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

  • 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 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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00624650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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