- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004494
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
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.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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New York
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Northport, New York, United States, 11768
- Veterans Affairs Medical Center - Northport
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Stony Brook, New York, United States, 11790-7775
- State University of New York Health Sciences Center - Stony Brook
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sami I. Said, State University of New York
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- Sepsis
- Syndrome
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Physiological Effects of Drugs
- Vasodilator Agents
- Gastrointestinal Agents
- Neuroprotective Agents
- Protective Agents
- Vasoactive Intestinal Peptide
Other Study ID Numbers
- 199/14275
- SUNY-SB-FDR001488
- SUNY-SB-96-077
- SUNY-SB-98-2606
- FD-R-0001488 (Other Grant/Funding Number: FDA Orphan Drug Products)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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