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Sponsors and Collaborators: |
FDA Office of Orphan Products Development State University of New York |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004494 |
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.
Condition | Intervention | Phase |
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Sepsis Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult |
Drug: vasoactive intestinal peptide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 18 |
Study Start Date: | September 1998 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, New York | |
State University of New York Health Sciences Center - Stony Brook | Recruiting |
Stony Brook, New York, United States, 11790-7775 | |
Contact: Sami I. Said 631-444-1754 | |
Veterans Affairs Medical Center - Northport | Recruiting |
Northport, New York, United States, 11768 | |
Contact: Sami I. Said 631-444-1754 |
Study Chair: | Sami I. Said | State University of New York |
Study ID Numbers: | 199/14275, SUNY-SB-FDR001488, SUNY-SB-96-077, SUNY-SB-98-2606 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004494 History of Changes |
Health Authority: | United States: Federal Government |
cardiovascular and respiratory diseases immunologic disorders and infectious disorders neonatal disorders |
rare disease respiratory distress syndrome sepsis |
Systemic Inflammatory Response Syndrome Vasodilator Agents Respiration Disorders Respiratory Distress Syndrome, Adult Rare Diseases Acute Respiratory Distress Syndrome Cardiovascular Agents |
Neuroprotective Agents Inflammation Sepsis Vasoactive Intestinal Peptide Respiratory Tract Diseases Lung Diseases Infant, Newborn, Diseases |
Systemic Inflammatory Response Syndrome Vasodilator Agents Disease Physiological Effects of Drugs Respiratory Distress Syndrome, Adult Respiration Disorders Gastrointestinal Agents Cardiovascular Agents Infection Protective Agents Neuroprotective Agents |
Pharmacologic Actions Inflammation Sepsis Pathologic Processes Vasoactive Intestinal Peptide Respiratory Tract Diseases Therapeutic Uses Syndrome Lung Diseases Central Nervous System Agents |