Comparative Evaluation of Albumin and Starch Effects in Acute Lung Injury (ALI) (CEASE)

Inclusion Criteria:

• Consensus clinical definition of ALI or ARDS:

  • PaO2 / FiO2 ratio ≤ 200 (ARDS) or ≤ 300 (ALI), and;
  • Bilateral infiltrates on chest x-ray, and;
  • No clinical evidence of congestive heart failure, and;
  • PAOP ≤ 18 mm Hg, if a pulmonary arterial catheter is present
• Serum total protein concentration < 6.0 g/dL.
• Endotracheal intubation and mechanical ventilation ≥ 24 hours.

Exclusion Criteria:

• Hemodynamic instability within the prior 24 hours: (either of the following)

  • Ongoing fluid resuscitation defined as > 2 liters of crystalloid boluses or > 4 units of blood products transfused in the prior 24-hour period.

  • Vasopressor support exceeding any of the following:

    • Dopamine or dobutamine > 5 mcg/kg/min, or in combination at any dose; or
    • Any other vasoactive agent (i.e. epinephrine, norepinephrine, phenylephrine)

• Significant renal disease (either of the following at the time of screening):

  • End-stage renal disease, or
  • Renal insufficiency with serum creatinine ≥ 3.0 mg/dL or urine output < 500cc/24 hrs
• Allergy to albumin, hetastarch or furosemide.

• Increased risk for bleeding:

  • Within 72 hours of any surgical procedure requiring use of the operating room, or
  • Any current or previously diagnosed bleeding disorder, or
  • History of any intracranial abnormality (including, but not limited to, intracranial arteriovenous malformations, subdural/subarachnoid/intracerebral hemorrhage, intracranial mass lesions) or traumatic brain injury with GCS < 9 in the prior 14 days, or
  • Prothrombin time international normalized ratio (INR) > 2.0, partial thromboplastin time (PTT) > 1.5 times control, platelet count < 50,000/cc3
• Risk for worsening pulmonary edema due to systolic heart failure.

• Technical pulse contour analysis limitations:

  • Absence of central venous catheter, clinical arterial vascular disease, severe hypothermia (core temperature < 94°F), weight < 40 kg or > 250 kg, clinically significant bleeding diathesis.
• Failure of the patient or nearest relative to provide informed consent.
• Refusal of the patient's attending physician to provide consent to participate.
• Age < 18 years.
• Pregnancy.
• Inability to quantify urine output (e.g. absence of bladder or bladder catheter).
• Significant hypokalemia (K+ < 3.5 meq/L), hypernatremia (Na+ > 155 meq/L) or hypomagnesemia (Mg < 1.0 meq/L)

• Patient meets criteria for weaning mechanical ventilation:

  • Required FiO2 ≤ 0.40 and PEEP ≤ 5, and;
  • Spontaneous tidal volumes > 5 ml / kg, and;
  • Spontaneous respiratory rate < 20 / minute, and;
  • Capable of spontaneous ventilation on CPAP=5, PS=5.
• Expected survival ≤ 120 hours.