Hemodynamics and Extravascular Lung Water in Acute Lung Injury

NCT00624650 | Completed Phase 2 Results DMC

• 2 other identifiers: IRB00003491IRB #e2978
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Lung Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  The first seven days of treatment

Study Arms (2)

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.

Drug: Diuresis (furosemide) part I; Other: Fluid Bolus (crystalloid or albumin); Drug: Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine); Drug: Dobutamine; Drug: Diuresis (furosemide) part II; Procedure: Dialysis

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.

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

Interventions

Diuresis (furosemide) part I DRUG

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

EVLW; Modified FACTT (control)

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

Modified FACTT (control)

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.

Modified FACTT (control)

Dobutamine DRUG

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

EVLW

Concentrate all drips and nutrition OTHER

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.

EVLW

Diuresis (furosemide) part II DRUG

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

EVLW; Modified FACTT (control)

Dialysis PROCEDURE

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.

EVLW; Modified FACTT (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age younger than 18 years old.
• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Pulsion Medical Systems: collaborator
• Oregon Clinical and Translational Research Institute: collaborator

Study Sites (3)

Kaiser Permanente Sunnyside

Clackamas, Oregon, 97015, United States

Location

Legacy Good Samaritan

Portland, Oregon, 97210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97219, United States

Location

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MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Interventions

Diuresis; Furosemide; Crystalloid Solutions; Albumins; Vasoconstrictor Agents; Norepinephrine; Vasopressins; Phenylephrine; Epinephrine; Dobutamine; Nutritional Status; Dialysis

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Proteins; Amino Acids, Peptides, and Proteins; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins; Phenethylamines; Ethylamines; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Limitations and Caveats

Principal Investigator departed the institution before Primary Outcome Measure analyses were conducted.

Results Point of Contact

• Title: Samantha Ruimy
• Organization: OHSU

ruimy@ohsu.edu

5034940724

Study Officials

• Charles Phillips, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 27, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-08

Locations

US (3)