OBJECTIVES: I. Determine the maximum tolerated dose of vasoactive intestinal peptide in patients with acute respiratory distress syndrome. II. Evaluate the safety and pharmacodynamic activity of this peptide in these patients.
- Study Type: Interventional
- Study Design
- Primary Purpose: Treatment
PROTOCOL OUTLINE: This is a dose escalation study. Patients receive vasoactive intestinal peptide (VIP) IV over either 6 or 12 hours. Cohorts of 3 patients each receive escalating doses of VIP over either 6 or 12 hours until the maximum tolerated dose is determined. Patients are followed for 30 days.
- Drug: vasoactive intestinal peptide
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Stony Brook University
- State University of New York
- Overall Official(s)
- Sami I. Said, Study Chair, State University of New York
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