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

Brief Title

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


Brief Summary

      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.
    

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 Phase

Phase 1

Study Type

Interventional




Condition

Sepsis

Intervention

vasoactive intestinal peptide


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

18

Start Date

September 1998



Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sami I. Said, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00004494

Organization ID

199/14275

Secondary IDs

SUNY-SB-FDR001488


Study Sponsor

Stony Brook University

Collaborators

 State University of New York

Study Sponsor

Sami I. Said, Study Chair, State University of New York


Verification Date

August 1999