NCT00004494

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Sepsis
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
DRUG	vasoactive intestinal peptide

Timeline

• Start date: 1998-09-01
• First posted: 1999-10-19
• Last updated: 2022-05-04

Locations

2 sites across 1 country: United States