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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 1999 by Stony Brook University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
State University of New York
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00004494
First received: October 18, 1999
Last updated: March 7, 2013
Last verified: August 1999
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00004494     History of Changes
Other Study ID Numbers: 199/14275, SUNY-SB-FDR001488, SUNY-SB-96-077, SUNY-SB-98-2606, FD-R-0001488
Study First Received: October 18, 1999
Last Updated: March 7, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Infant, Newborn, Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Sepsis
Toxemia
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Vasoactive Intestinal Peptide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014