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

NCT00004494 | Completed Phase 1

• 5 other identifiers: 199/14275SUNY-SB-FDR001488SUNY-SB-96-077SUNY-SB-98-2606FD-R-0001488
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Sepsis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Adult

Keywords

cardiovascular and respiratory diseases; immunologic disorders and infectious disorders; neonatal disorders; rare disease; respiratory distress syndrome; sepsis

Interventions

vasoactive intestinal peptide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Stony Brook University: lead
• State University of New York: collaborator
• FDA Office of Orphan Products Development: collaborator

Study Sites (2)

Veterans Affairs Medical Center - Northport

Northport, New York, 11768, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-7775, United States

Location

MeSH Terms

Conditions

Sepsis; Respiratory Distress Syndrome; Respiratory Tract Diseases; Immune System Diseases; Communicable Diseases; Infant, Newborn, Diseases; Rare Diseases

Interventions

Vasoactive Intestinal Peptide

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiration Disorders; Disease Attributes; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Sami I. Said

  State University of New York

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: September 1, 1998
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

US (2)