Clinical Trial: Hemodynamics and Extravascular Lung Water in Acute Lung Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Oregon Health and Science University

Current Primary Outcome: The primary efficacy variable will be the total reduction in measured lung water [ Time Frame: The first seven days of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The number of ventilator-free days (VFDs [ Time Frame: number of days after initiating unassisted breathing to day 28 after randomization, assuming a patient survives for at least 2 consecutive days after initiating unassisted breathing and remains free of assisted breathing. ]
  • The physiologic severity of clinical lung injury as measured by the 4-point acute lung injury scoring system. [ Time Frame: Day 1-28 ]
  • Number of ICU-free days [ Time Frame: From randomization to day 28 ]
  • Number of Organ Failure Free Days [ Time Frame: Randomization to day 28 ]
  • Percentage of patients alive at day 28 in patients with ALI [ Time Frame: Day 28 ]
  • Percentage of patients discharged alive from hospital within 60 days [ Time Frame: Day 60 ]
  • Mortality and VFDs in patients with pre- randomization PaO2/FiO2 less than or equal to 200 [ Time Frame: Day 60 ]
  • Mortality prior to hospital discharge to day 60 in patients who receive norepinephrine, dobutamine, or vasopressin at any point during the treatment period [ Time Frame: Day 60 ]
  • number of VFDs to day 28 in patients who receive the following intravenous vasoactive agonists (norepinephrine, dobutamine, and vasopressin) at any point during the treatment period [ Time Frame: Day 28 ]
  • Mortality prior to hospital discharge to day 60 in patients with shock (defined in 2.3.6 in the HEAL protocol) at the time of randomization [ Time Frame: Day 60 ]
  • number of VFDs to day 28 in patients with shock (defined in 2.3.6 in the HEAL protocol) at the time of randomization [ Time Frame: Day 28 ]
  • Mortality prior to hospital discharge to day 60 in patients with severe sepsis (defined in 2.3.8 in the HEAL protocol) at the time of randomization. [ Time Frame: Day 60 ]
  • number of ventilator-free days to day 28 in patients with severe sepsis (defined in 2.3.8) at the time of randomization. [ Time Frame: Day 28 ]
  • Changes in quasistatic total respiratory system compliance [ Time Frame: Randomization to day 28 ]
  • Need for vasoactive medication - dose, duration and total amounts of all vasoactive medications. [ Time Frame: Randomization to day 28 ]
  • Changes in the plasma levels of interleukin-1b, 6 and 8, and TNF-α. [ Time Frame: 60 days ]
  • Changes in the airspace (bronchoalveolar lavage: BAL) levels of interleukin-1b, 6 and 8, and TNF-α. Changes in BAL cell count and differential. [ Time Frame: 60 days ]


Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: February 19, 2008
Date Started: February 2008
Date Completion:
Last Updated: May 27, 2011
Last Verified: July 2010