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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.
 
ClinicalTrials.gov Identifier: NCT00004494
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : May 4, 2022
Sponsor:
Collaborators:
State University of New York
FDA Office of Orphan Products Development
Information provided by:
Stony Brook University

Tracking Information
First Submitted Date  ICMJE October 18, 1999
First Posted Date  ICMJE October 19, 1999
Last Update Posted Date May 4, 2022
Study Start Date  ICMJE September 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
Official Title  ICMJE Not Provided
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Sepsis
  • Respiratory Distress Syndrome
  • Respiratory Distress Syndrome, Adult
Intervention  ICMJE Drug: vasoactive intestinal peptide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
18
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004494
Other Study ID Numbers  ICMJE 199/14275
SUNY-SB-FDR001488
SUNY-SB-96-077
SUNY-SB-98-2606
FD-R-0001488 ( Other Grant/Funding Number: FDA Orphan Drug Products )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stony Brook University
Original Study Sponsor  ICMJE FDA Office of Orphan Products Development
Collaborators  ICMJE
  • State University of New York
  • FDA Office of Orphan Products Development
Investigators  ICMJE
Study Chair: Sami I. Said State University of New York
PRS Account Stony Brook University
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP