SepsisPhase 1NCT00004494
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
A Phase 1 study testing vasoactive intestinal peptide in people with Sepsis and Respiratory Distress Syndrome, run by Stony Brook University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Respiratory Distress Syndrome, Respiratory Distress Syndrome, Adult
- What is being tested?
- vasoactive intestinal peptide
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1998to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Veterans Affairs Medical Center - Northport
Northport, New York, 11768
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
About this study
OBJECTIVES:
- 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.
Read the 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.
- Being tested
- vasoactive intestinal peptide
- Keywords
- cardiovascular and respiratory diseases, immunologic disorders and infectious disorders, neonatal disorders, rare disease, respiratory distress syndrome, sepsis
- Medical subject headings
- Sepsis, Respiratory Distress Syndrome, Respiratory Tract Diseases, Immune System Diseases, Communicable Diseases, Infant, Newborn, Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vasoactive intestinal peptideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York, FDA Office of Orphan Products Development
- Investigators
- Sami I. Said, Study chair, State University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004494
- Sponsor's protocol ID
- 199/14275
- Other IDs
- SUNY-SB-FDR001488, SUNY-SB-96-077, SUNY-SB-98-2606, FD-R-0001488
- Status last verified
- May 2022
- First submitted
- 18 Oct 1999
- Last updated
- 4 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
- ClinicalTrials.gov ID
- NCT00004494
- Acronym / sponsor ID
- 199/14275
- Keywords
- cardiovascular and respiratory diseases, immunologic disorders and infectious disorders, neonatal disorders, rare disease, respiratory distress syndrome, sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- State University of New York, FDA Office of Orphan Products Development
- Study start
- Sep 1998
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vasoactive intestinal peptide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sami I. Said study chair
State University of New York
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vasoactive intestinal peptide in people with Sepsis and Respiratory Distress Syndrome, run by Stony Brook University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.