Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
Recruitment status was: Recruiting
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.
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Adult
Drug: vasoactive intestinal peptide
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||September 1998|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004494
|United States, New York|
|Veterans Affairs Medical Center - Northport|
|Northport, New York, United States, 11768|
|State University of New York Health Sciences Center - Stony Brook|
|Stony Brook, New York, United States, 11790-7775|
|Study Chair:||Sami I. Said||State University of New York|