Hemodynamics and Extravascular Lung Water in Acute Lung Injury

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

3 sites in 1 country.

About this study

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

Conditions

Acute Lung Injury

Being tested

Diuresis (furosemide) part I, Fluid Bolus (crystalloid or albumin), Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine), Dobutamine, Concentrate all drips and nutrition

Keywords

Acute Lung Injury, Extravascular Lung Water, Acute Respiratory Distress Syndrome

Medical subject headings

Acute Lung Injury, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Diuresis (furosemide) part IDrug

  Goal: Overall I/O net negative 50ml/hour

  Initiation:

  1. Continuous IV furosemide at 3mg/hour or last known protocol specified dose
  2. Titrate up or down by 3mg/hour increments every hour as needed to establish diuresis goal
  3. Do not exceed 30mg/hour

  Furosemide Bolus:

  1. If unable to establish adequate diuresis at maximum dose may attempt furosemide bolusing as follows
  2. By intravenous bolus give 30, then 60, then 80, and 120 mg - one bolus dose every hour until urine output results in 1 ml/kg PBW/hr net negative fluid balance per hour
  3. Bolusing trials may be done at will but total furosemide dose may not exceed 800mg/24hour period

• Fluid Bolus (crystalloid or albumin)Other

  15 ml/kg PBW crystalloid (round to nearest 250 ml) or 25 grams albumin as rapidly as possible. Used for patients with a measured CVP<8 or measured PaOP <12mmHg in addition to concurrent urine output of <0.5 ml/kg/hr

• Fluid Bolus (crystalloid or albumin)Other

  10 ml/kg PBW crystalloid (round to nearest 70ml) or 25 grams albumin as rapidly as possible.

  Perform thermodilution immediately before and after and 60 minutes after each bolus. If EVLW increases > 2ml/kg PBW within 60 minutes after a bolus do not give any further boluses until next regularly scheduled measurement. This therapy is available for patients with a map < 60 or who are on vasopressors that also have a measured GEDI less than goal

• Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)Drug

  (may use any alone or in combination)

  1. Norepinephrine - 0.05mcg/kg/min - increase for effect not to exceed (NTE) 1mcg/kg/min.
  2. Vasopressin - 0.04 international units/hour
  3. Phenylephrine - 7mcg/min - may increase to for effect not to exceed 500mcg/min.
  4. Epinephrine - 1 mcg/min - may increase for effect not to exceed 20mcg/min.

  Weaning: When MAP ≥ 60 mm/Hg on stable dose of vasopressor begin reduction of vasopressor by greater than or equal to 25% stabilizing dose at intervals ≤ 4 hours to maintain MAP ≥ 60 mm/Hg.

• Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)Drug

  (may use alone or in combination)

  1. Norepinephrine - 0.05mcg/kg/min - increase for effect not to exceed (NTE) 1mcg/kg/min.
  2. Vasopressin - 0.04 international units/hour
  3. Phenylephrine - 7mcg/min - may increase to for effect not to exceed 500mcg/min.
  4. Epinephrine - 1 mcg/min - may increase for effect not to exceed 20mcg/min.

  Weaning: When MAP ≥ 60 mm/Hg on stable dose of vasopressor begin reduction of vasopressor by greater than or equal to 25% stabilizing dose at intervals ≤ 4 hours to maintain MAP ≥ 60 mm/Hg.

  In the experimental arm vasopressors are a treatment option in patients with a Mean Arterial Pressure of < 60

• DobutamineDrug

  1. Begin at 5mcg/kg/min and increase by 3 mcg/kg/min increments at 15 minute intervals until C.I. ≥ 2.5 or maximum dose of 20mcg/kg/min has been reached.
  2. Begin weaning 4 hours after low CI is reversed. Wean by ≥ 25% of the stabilizing dose at intervals of ≤ 4 hours to maintain hemodynamic algorithm goals.
  3. If patient is on dobutamine as a result of an earlier cell assignment, dobutamine should be ignored for the purpose of subsequent assignment, but should be continued to be weaned per protocol.

  Used in patients with a measured cardiac index < 2.5

• DobutamineDrug

  1. Begin at 5mcg/kg/min and increase by 3 mcg/kg/min increments at 15 minute intervals until C.I. ≥ 2.5 or maximum dose of 20mcg/kg/min has been reached.
  2. Begin weaning 4 hours after low CI is reversed. Wean by ≥ 25% of the stabilizing dose at intervals of ≤ 4 hours to maintain hemodynamic algorithm goals.
  3. If patient is on dobutamine as a result of an earlier cell assignment, dobutamine should be ignored for the purpose of subsequent assignment, but should be continued to be weaned per protocol.

• Concentrate all drips and nutritionOther

  Concentrate all drips and nutrition in order to minimize fluid volume as much as possible. Intravenous fluid to be run at keep vein open rate.

  EVLW arm: Patients with a MAP > 60 and off vasopressors for >12 hours, as well as patients with a measured cardiac index >2.5 that also have a measured GEDI > goal.

• Diuresis (furosemide) part IIDrug

  Withhold furosemide if:

  1. Significant hypokalemia (K+ <= 2.5 meq/L), or hypernatremia (Na+ >= 155 meq/L) occurs within last 12 hours may then be restarted if the prevailing condition no longer exists
  2. Dialysis dependence
  3. Oliguria (less than 0.5ml/kg/hour) with either creatinine > 3, or clinical suspicion of rapidly evolving ARF
  4. More than 800mg has been given in less then 24 hours
  5. Creatinine increases > 1.5 mg/dl in any 24 hour period

• DialysisProcedure or surgery

  1. Need for CVVHD or intermittent hemodialysis to be determined by treating clinicians.
  2. CVC arm: If fluid management to be accomplished with dialysis then fluid balance goals to be determined per clinicians.
  3. EVLW arm: Fluid balance as per algorithm
  4. When using intermittent HD it is recommended that no more than 2 liters net negative fluid is removed per dialysis session. Total fluid removal per run to be estimated by the clinicians to attain CVP or GEDI goals per algorithm.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. The Primary Efficacy Variable Will be the Total Reduction in Measured Lung Water

   Measured: The first seven days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted27 Feb 2008 (estimated)
2. Study startFeb 2008
3. Primary completionJan 2011
4. Study completionJan 2011

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (79)Papers the sponsor has linked to this study.
• Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
• More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.