Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00004494
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
1999-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
Sponsor:
Stony Brook University
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: