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Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
This study is currently recruiting participants.
Verified by FDA Office of Orphan Products Development, August 1999
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: FDA Office of Orphan Products Development
State University of New York
Information provided by: FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier: NCT00004494
  Purpose

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
Sepsis
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Adult
Drug: vasoactive intestinal peptide
Phase I

MedlinePlus related topics: Sepsis
Drug Information available for: Vasoactive intestinal peptide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 18
Study Start Date: September 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004494

Locations
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        
Sponsors and Collaborators
State University of New York
Investigators
Study Chair: Sami I. Said State University of New York
  More Information

No publications provided

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

Keywords provided by FDA Office of Orphan Products Development:
cardiovascular and respiratory diseases
immunologic disorders and infectious disorders
neonatal disorders
rare disease
respiratory distress syndrome
sepsis

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009