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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004494
Recruitment Status : Unknown
Verified August 1999 by Stony Brook University.
Recruitment status was:  Recruiting
First Posted : October 19, 1999
Last Update Posted : March 8, 2013
State University of New York
FDA Office of Orphan Products Development
Information provided by:
Stony Brook University

Brief Summary:


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 or disease Intervention/treatment Phase
Sepsis Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult Drug: vasoactive intestinal peptide Phase 1

Detailed Description:


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 : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Primary Purpose: Treatment
Study Start Date : September 1998

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004494

United States, New York
Veterans Affairs Medical Center - Northport Recruiting
Northport, New York, United States, 11768
Contact: Sami I. Said    631-444-1754      
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      
Sponsors and Collaborators
Stony Brook University
State University of New York
FDA Office of Orphan Products Development
Study Chair: Sami I. Said State University of New York Identifier: NCT00004494     History of Changes
Other Study ID Numbers: 199/14275
FD-R-0001488 ( Other Grant/Funding Number: FDA Orphan Drug Products )
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: August 1999

Keywords provided by Stony Brook University:
cardiovascular and respiratory diseases
immunologic disorders and infectious disorders
neonatal disorders
rare disease
respiratory distress syndrome

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Systemic Inflammatory Response Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Vasoactive Intestinal Peptide
Gastrointestinal Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs