Back to resultsHemodynamics and Extravascular Lung Water in Acute Lung Injury (HEAL)
Primary Purpose
Acute Lung Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diuresis (furosemide) part I
Fluid Bolus (crystalloid or albumin)
Fluid Bolus (crystalloid or albumin)
Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)
Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)
Dobutamine
Dobutamine
Concentrate all drips and nutrition
Diuresis (furosemide) part II
Dialysis
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury focused on measuring Acute Lung Injury, Extravascular Lung Water, Acute Respiratory Distress Syndrome
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 < 30, bilateral femoral arterial grafts, INR > 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).
Sites / Locations
- Kaiser Permanente Sunnyside
- Legacy Good Samaritan
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Modified FACTT (control)
EVLW
Arm Description
The investigators control arm consists of a simplified algorithm for conservative management of fluids in patients with ALI, as to be published by the ARDSnet group, based on the protocol used in the FACTT trial. The protocol calls for strict adherence to ARDSnet ventilation, our weaning protocol and use of only select vasoactive, beta-adrenergic drugs as it is felt that variation in these treatments could seriously confound our results. Albuterol administration will not be permitted in the either arm except for life threatening bronchospasm not responsive to ipratropium. Ipratropium may be administered at the treating physician's discretion for bronchospasm. PiCCO's will be placed in each control patient and data recorded twice daily. The treating physician's will be blinded to this data.
When EVLW exceeds 9 ml/kg PBW the algorithmic treatment is begun and continued until EVLW ≤9 ml/kg PBW or extubation whichever comes first as tolerated (see figure 6). Furosemide and volume contraction are initiated when sufficient volumetric preload (GEDI) is available to enact volume contraction as a means to decrease measured EVLW without causing concomitant hypoperfusion. Fluid administration is also guided by changes in EVLW. An increase in EVLW > 2ml/kg PBW as a result of fluid administration curtails any further fluid administration until the next scheduled measurement. Our ultimate treatment goal is to maximally lower EVLW towards the normal range - thus improving lung mechanics and gas exchange - without causing concomitant hemodynamic compromise and end-organ injury. By doing so we feel this algorithmic, goal directed, therapeutic approach should improve outcome.
Outcomes
Primary Outcome Measures
The Primary Efficacy Variable Will be the Total Reduction in Measured Lung Water
Secondary Outcome Measures
Full Information
NCT ID
NCT00624650
First Posted
February 19, 2008
Last Updated
August 21, 2019
Sponsor
Oregon Health and Science University
Collaborators
Pulsion Medical Systems, Oregon Clinical and Translational Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00624650
Brief Title
Hemodynamics and Extravascular Lung Water in Acute Lung Injury
Acronym
HEAL
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
Pulsion Medical Systems, Oregon Clinical and Translational Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
Acute Lung Injury, Extravascular Lung Water, Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified FACTT (control)
Arm Type
Active Comparator
Arm Description
The investigators control arm consists of a simplified algorithm for conservative management of fluids in patients with ALI, as to be published by the ARDSnet group, based on the protocol used in the FACTT trial. The protocol calls for strict adherence to ARDSnet ventilation, our weaning protocol and use of only select vasoactive, beta-adrenergic drugs as it is felt that variation in these treatments could seriously confound our results. Albuterol administration will not be permitted in the either arm except for life threatening bronchospasm not responsive to ipratropium. Ipratropium may be administered at the treating physician's discretion for bronchospasm. PiCCO's will be placed in each control patient and data recorded twice daily. The treating physician's will be blinded to this data.
Arm Title
EVLW
Arm Type
Experimental
Arm Description
When EVLW exceeds 9 ml/kg PBW the algorithmic treatment is begun and continued until EVLW ≤9 ml/kg PBW or extubation whichever comes first as tolerated (see figure 6). Furosemide and volume contraction are initiated when sufficient volumetric preload (GEDI) is available to enact volume contraction as a means to decrease measured EVLW without causing concomitant hypoperfusion. Fluid administration is also guided by changes in EVLW. An increase in EVLW > 2ml/kg PBW as a result of fluid administration curtails any further fluid administration until the next scheduled measurement.
Our ultimate treatment goal is to maximally lower EVLW towards the normal range - thus improving lung mechanics and gas exchange - without causing concomitant hemodynamic compromise and end-organ injury. By doing so we feel this algorithmic, goal directed, therapeutic approach should improve outcome.
Intervention Type
Drug
Intervention Name(s)
Diuresis (furosemide) part I
Intervention Description
Goal: Overall I/O net negative 50ml/hour
Initiation:
Continuous IV furosemide at 3mg/hour or last known protocol specified dose
Titrate up or down by 3mg/hour increments every hour as needed to establish diuresis goal
Do not exceed 30mg/hour
Furosemide Bolus:
If unable to establish adequate diuresis at maximum dose may attempt furosemide bolusing as follows
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
Bolusing trials may be done at will but total furosemide dose may not exceed 800mg/24hour period
Intervention Type
Other
Intervention Name(s)
Fluid Bolus (crystalloid or albumin)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Fluid Bolus (crystalloid or albumin)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)
Intervention Description
(may use any alone or in combination)
Norepinephrine - 0.05mcg/kg/min - increase for effect not to exceed (NTE) 1mcg/kg/min.
Vasopressin - 0.04 international units/hour
Phenylephrine - 7mcg/min - may increase to for effect not to exceed 500mcg/min.
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.
Intervention Type
Drug
Intervention Name(s)
Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)
Intervention Description
(may use alone or in combination)
Norepinephrine - 0.05mcg/kg/min - increase for effect not to exceed (NTE) 1mcg/kg/min.
Vasopressin - 0.04 international units/hour
Phenylephrine - 7mcg/min - may increase to for effect not to exceed 500mcg/min.
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
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
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.
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.
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
Intervention Type
Drug
Intervention Name(s)
Dobutamine
Intervention Description
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.
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.
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.
Intervention Type
Other
Intervention Name(s)
Concentrate all drips and nutrition
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Diuresis (furosemide) part II
Intervention Description
Withhold furosemide if:
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
Dialysis dependence
Oliguria (less than 0.5ml/kg/hour) with either creatinine > 3, or clinical suspicion of rapidly evolving ARF
More than 800mg has been given in less then 24 hours
Creatinine increases > 1.5 mg/dl in any 24 hour period
Intervention Type
Procedure
Intervention Name(s)
Dialysis
Intervention Description
Need for CVVHD or intermittent hemodialysis to be determined by treating clinicians.
CVC arm: If fluid management to be accomplished with dialysis then fluid balance goals to be determined per clinicians.
EVLW arm: Fluid balance as per algorithm
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.
Primary Outcome Measure Information:
Title
The Primary Efficacy Variable Will be the Total Reduction in Measured Lung Water
Time Frame
The first seven days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 30, bilateral femoral arterial grafts, INR > 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Phillips, M.D.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Sunnyside
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Legacy Good Samaritan
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
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Hemodynamics and Extravascular Lung Water in Acute Lung Injury
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