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Phase I Study of Vasoactive Intestinal Peptide in Patients with Acute Respiratory Distress Syndrome and Sepsis
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development State University of New York
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
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.
Condition | Treatment or Intervention | Phase |
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Sepsis Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult |
Drug: vasoactive intestinal peptide |
Phase I |
MedlinePlus related topics: Premature Babies; Respiratory Diseases; Sepsis
Study Type: Interventional
Study Design: Treatment
Expected Total Enrollment: 18
Study start: September 1998
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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