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

Phase 1

Completed

• Conditions: Respiratory Distress Syndrome; Sepsis; Respiratory Distress Syndrome, Adult

• Registration Number: NCT00004494
• Lead Sponsor: Stony Brook University

Brief 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.

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Veterans Affairs Medical Center - Northport; 🇺🇸 Northport, New York, United States

State University of New York Health Sciences Center - Stony Brook; 🇺🇸 Stony Brook, New York, United States