Sepsis Clinical Trial
NCT number | NCT00004494 |
Other study ID # | 199/14275 |
Secondary ID | SUNY-SB-FDR00148 |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | September 1998 |
Verified date | May 2022 |
Source | Stony Brook University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | |
Est. primary completion date | |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Stony Brook University | FDA Office of Orphan Products Development, State University of New York |
United States,
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