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Home > "P" Clinical Trials Conditions > Phase I Study of Vasoactive Intestinal Peptide in Patients with Acute Respiratory Distress Syndrome and Sepsis  Phase I Study of Vasoactive Intestinal Peptide in Patients with Acute Respiratory Distress Syndrome and Sepsis
Phase I Study of Vasoactive Intestinal Peptide in Patients with Acute Respiratory Distress Syndrome and Sepsis
For Condition: Respiratory Distress Syndrome,Sepsis,Respiratory Distress Syndrome, Adult
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , State University of New York
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
SamiSaid, Study Chair, State University of New York
Veterans Affairs Medical Center - Northport *Recruiting*
Northport, New York, 11768
United States
Recruiting Sami Said 631-444-1754
State University of New York Health Sciences Center - Stony Brook *Recruiting*
Stony Brook, New York, 11790-7775
United States
Recruiting Sami Said 631-444-1754
Additional Information:
Study ID Numbers: 199/14275; SUNY-SB-FDR001488,SUNY-SB-96-077,SUNY-SB-98-2606
Study Start Date: September 1998
Record last reviewed: August 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004494
Other Sepsis Studies:
1. A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy with GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer
2. A Safety and Efficacy Study of Hospitalized Patients with Community-Acquired Pneumonia and Sepsis
3. A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.
4. The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients with Severe Sepsis
5. Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis
Related Studies:
Other Sepsis Clinical Trials
Other New York Clinical Trials
Other Northport Clinical Trials
Phase I Study of Vasoactive Intestinal Peptide in Patients with Acute Respiratory Distress Syndrome and Sepsis
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