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Sponsors and Collaborators: |
Oregon Health and Science University Pulsion Medical Systems Oregon Clinical and Translational Research Institute |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00624650 |
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.
Condition | Intervention | Phase |
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Acute Lung Injury |
Drug: Diuresis (furosemide) part I Other: Fluid Bolus (crystalloid or albumin) Drug: Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine) Drug: Dobutamine Other: Concentrate all drips and nutrition Drug: Diuresis (furosemide) part II Procedure: Dialysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Hemodynamics and Extravascular Lung Water in Acute Lung Injury: A Prospective Randomized Controlled Multicentered Trial of Goal Directed Treatment of EVLW Vs Standard Management for the Treatment of Acute Lung Injury |
Estimated Enrollment: | 72 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Modified FACTT (control): Active Comparator
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.
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Drug: Diuresis (furosemide) part I
Goal: Overall I/O net negative 50ml/hour Initiation:
Furosemide Bolus:
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
Drug: Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)
(may use any alone or in combination)
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.
Withhold furosemide if:
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EVLW: Experimental
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.
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Drug: Diuresis (furosemide) part I
Goal: Overall I/O net negative 50ml/hour Initiation:
Furosemide Bolus:
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 (may use alone or in combination)
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
Used in patients with a measured cardiac index < 2.5
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.
Drug: Diuresis (furosemide) part II
Withhold furosemide if:
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To conduct a randomized, controlled trial of a goal directed therapy designed to improve outcome in patients with acute lung injury (ALI). We 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acute onset of:
Exclusion Criteria:
Contact: Alex Nielsen | 503-494-0724 | nielseal@ohsu.edu |
Contact: Charles Phillips, M.D. | 503-494-2465 | phillipc@ohsu.edu |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97219 | |
Contact: Alex Nielsen 503-494-0724 nielseal@ohsu.edu | |
Contact: Kathy Bacon, B.S. 503-494-6949 baconka@ohsu.edu | |
Principal Investigator: Charles Phillips, M.D. | |
Sub-Investigator: Jennifer Letourneau, D.O. | |
Legacy Good Samaritan | Recruiting |
Portland, Oregon, United States, 97210 | |
Contact: Susan Staat, RN 503-413-8330 sstaat@lhs.org | |
Principal Investigator: Brian Young, M.D. | |
Kaiser Permanente Sunnyside | Recruiting |
Clackamas, Oregon, United States, 97015 | |
Contact: Kathy Arnold 503-331-6017 kathleen.ann.arnold@kp.org | |
Principal Investigator: David Schmidt, M.D. |
Principal Investigator: | Charles Phillips, M.D. | Oregon Health and Science University |
Responsible Party: | Oregon Health and Science University ( Charles Phillips, M.D., Associate Professor of Medicine ) |
Study ID Numbers: | IRB00003491, IRB #e2978 |
Study First Received: | February 19, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00624650 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute Lung Injury Extravascular Lung Water Acute Respiratory Distress Syndrome |
Neurotransmitter Agents Adrenergic Agents Diuretics Respiratory Distress Syndrome, Adult Benzocaine Furosemide Adrenergic Agonists Nasal Decongestants Arginine Vasopressin Respiratory Tract Diseases Phenylephrine Vasopressins Vasoconstrictor Agents Epinephrine Pseudoephedrine |
Adrenergic alpha-Agonists Adrenergic beta-Agonists Arginine Respiration Disorders Acute Respiratory Distress Syndrome Anti-Asthmatic Agents Cardiovascular Agents Hemostatics Dobutamine Oxymetazoline Mydriatics Lung Diseases Norepinephrine Ephedrine Peripheral Nervous System Agents |
Respiratory System Agents Neurotransmitter Agents Coagulants Molecular Mechanisms of Pharmacological Action Adrenergic Agents Cardiotonic Agents Diuretics Hematologic Agents Respiratory Distress Syndrome, Adult Physiological Effects of Drugs Furosemide Adrenergic Agonists Nasal Decongestants Membrane Transport Modulators Arginine Vasopressin |
Respiratory Tract Diseases Phenylephrine Therapeutic Uses Vasoconstrictor Agents Vasopressins Epinephrine Adrenergic alpha-Agonists Adrenergic beta-Agonists Sympathomimetics Respiration Disorders Anti-Asthmatic Agents Cardiovascular Agents Protective Agents Hemostatics Dobutamine |