Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004494
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
1999-10-18
Brief Title:
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
Sponsor:
Stony Brook University
Organization:
Stony Brook University
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FD-R-0001488 | OTHER_GRANT | FDA Orphan Drug Products | None |
| SUNY-SB-FDR001488 | None | None | None |
| SUNY-SB-96-077 | None | None | None |
| SUNY-SB-98-2606 | None | None | None |