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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment

Detailed Description

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.

Interventions

  • 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

Investigator Details

  • Lead Sponsor
    • Stony Brook University
  • Collaborator
    • State University of New York
  • Overall Official(s)
    • Sami I. Said, Study Chair, State University of New York

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.