Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis

You may be eligible if

• PROTOCOL ENTRY CRITERIA:
• -Disease Characteristics--
• Diagnosis of adult respiratory distress syndrome (ARDS) with sepsis
• ARDS characterized by: hypoxemia refractory to supplemental oxygen therapy, diffuse pulmonary infiltrates, no cardiogenic cause of pulmonary edema, and reduced pulmonary compliance
• Sepsis characterized by: Two or more of the following: Fever or hypothermia; Tachycardia; Tachypnea; WBC greater than 12,000/mm3 or less than 4,000/mm3 or immature neutrophils; Hypotension; Clinical suspicion of infection; Inadequate organ perfusion or organ dysfunction as demonstrated by: Acute deterioration in mental acuity (excluding sedatives or other nonsepsis causes) OR Unexplained metabolic acidosis OR Oliguria for greater than 2 hours OR Unexplained coagulopathy (elevated PT or PTT or platelet count decreased to less than 50% of baseline within 24 hours or less than 100,000/mm3) OR Acute elevation of bilirubin to greater than 2.0 mg/dL AND elevation of alkaline phosphatase, SGOT, or SGPT
• No sepsis with unstable BP
• -Prior/Concurrent Therapy--
• At least 30 days since prior enrollment in investigational trial; No other concurrent enrollment in investigational trial
• -Patient Characteristics--
• Hematopoietic: See Disease Characteristics; No uncontrolled hemorrhage (transfusion of 4 or more units required within past 24 hours); No chemotherapy induced neutropenia (granulocyte count less than 1000/mm3)
• Hepatic: No severe liver disease with portal hypertension
• Renal: No anuria (urine output less than 50 mL/day)
• Cardiovascular: No cardiogenic shock
• Neurologic: No recent stroke, head trauma, or increased intracranial pressure; No other serious neurologic disorder
• Other: Not pregnant; No acquired immune deficiency syndrome; No immunosuppressed transplant patients; No severe burns; No irreversible underlying condition with rapidly fatal course; No marked obesity; No recent history of diarrhea