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

This is an interventional treatment trial for Lung Injury, Acute (ALI) focused on measuring Acute lung injury (ALI), Acute respiratory distress syndrome (ARDS), Respiratory failure Read More

Inclusion Criteria:

• Consensus clinical definition of ALI or ARDS:

  • Partial pressure of oxygen in arterial blood to the fraction of inspired oxygen (PaO2 / FiO2) ratio ≤ 200 (ARDS) or ≤ 300 (ALI), and;
  • Bilateral infiltrates on chest x-ray, and;
  • No clinical evidence of congestive heart failure, and;
  • Pulmonary artery occlusion pressure (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 Glasgow Coma Scal (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 positive end-expiratory pressure (PEEP) ≤ 5, and;
  • Spontaneous tidal volumes > 5 ml / kg, and;
  • Spontaneous respiratory rate < 20 / minute, and;
  • Capable of spontaneous ventilation on continuous positive airway pressure (CPAP)=5, pressure support (PS)=5.
• Expected survival ≤ 120 hours.