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Phase 2 Completed N=33 Randomized Single-blind Treatment

Hemodynamics and Extravascular Lung Water in Acute Lung Injury

Source: ClinicalTrials.gov NCT00624650 ↗
Enrolled (actual)
33
Serious AEs
21.2%
Results posted
Sep 2019
Primary outcomePrimary: 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.

Outcome Measures

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

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. Informational only — not medical advice.

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