Hemodynamics and Extravascular Lung Water in Acute Lung Injury

PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Acute Lung Injury
Interventions
DRUG

Diuresis (furosemide) part I

"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"

OTHER

Fluid Bolus (crystalloid or albumin)

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

OTHER

Fluid Bolus (crystalloid or albumin)

"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"

DRUG

Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)

"(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."

DRUG

Vasopressors (Norepinephrine, Vasopressin, Phenylephrine, Epinephrine)

"(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"

DRUG

Dobutamine

"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"

DRUG

Dobutamine

"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."

OTHER

Concentrate all drips and nutrition

"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:~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"

PROCEDURE

Dialysis

"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."

Trial Locations (3)

97015

Kaiser Permanente Sunnyside, Clackamas

97210

Legacy Good Samaritan, Portland

97219

Oregon Health and Science University, Portland

All Listed Sponsors
collaborator

Pulsion Medical Systems

INDUSTRY

collaborator

Oregon Clinical and Translational Research Institute

OTHER

lead

Oregon Health and Science University

OTHER