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

Sepsis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004494
• Other study ID #: 199/14275
• Secondary ID: SUNY-SB-FDR00148
• Status: Completed
• Phase: Phase 1
• Start date: September 1998

Study information

• Verified date: May 2022
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of adult respiratory distress syndrome (ARDS) with sepsis

ARDS characterized by: hypoxemia refractory to supplemental oxygen therapy, diffuse pulmonary infiltrates, no cardiogenic cause of pulmonary edema, and reduced pulmonary compliance

Sepsis characterized by: Two or more of the following: Fever or hypothermia; Tachycardia; Tachypnea; WBC greater than 12,000/mm3 or less than 4,000/mm3 or immature neutrophils; Hypotension; Clinical suspicion of infection; Inadequate organ perfusion or organ dysfunction as demonstrated by: Acute deterioration in mental acuity (excluding sedatives or other nonsepsis causes) OR Unexplained metabolic acidosis OR Oliguria for greater than 2 hours OR Unexplained coagulopathy (elevated PT or PTT or platelet count decreased to less than 50% of baseline within 24 hours or less than 100,000/mm3) OR Acute elevation of bilirubin to greater than 2.0 mg/dL AND elevation of alkaline phosphatase, SGOT, or SGPT

No sepsis with unstable BP

--Prior/Concurrent Therapy--

At least 30 days since prior enrollment in investigational trial; No other concurrent enrollment in investigational trial

--Patient Characteristics--

Hematopoietic: See Disease Characteristics; No uncontrolled hemorrhage (transfusion of 4 or more units required within past 24 hours); No chemotherapy induced neutropenia (granulocyte count less than 1000/mm3)

Hepatic: No severe liver disease with portal hypertension

Renal: No anuria (urine output less than 50 mL/day)

Cardiovascular: No cardiogenic shock

Neurologic: No recent stroke, head trauma, or increased intracranial pressure; No other serious neurologic disorder

Other: Not pregnant; No acquired immune deficiency syndrome; No immunosuppressed transplant patients; No severe burns; No irreversible underlying condition with rapidly fatal course; No marked obesity; No recent history of diarrhea

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Syndrome

Intervention

Drug:
• vasoactive intestinal peptide

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - Northport	Northport	New York
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York

Sponsors (3)

Lead Sponsor	Collaborator
Stony Brook University	FDA Office of Orphan Products Development, State University of New York

Country where clinical trial is conducted

United States,