- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319631
Role of Vascular Endothelial Growth Factor (VEGF) in Acute Lung Injury/Adult Respiratory Distress Syndrome (ARDS)
Study Overview
Status
Conditions
Detailed Description
In previous lab experiments, we observed evidence of pulmonary edema following alveolar epithelial overexpression of VEGF, suggesting a potential role for VEGF in ARDS. In addition, we found that preventing VEGF from reaching its target receptor(s) by overexpressing a soluble form of a VEGF receptor protein prevents edema formation.
These observations heighten the plausibility of VEGF playing an important role in the development of increased pulmonary capillary permeability during acute lung injury. Understanding this role VEGF plays in ARDS consequently provides an ideal opportunity to discover new therapies for ARDS.
Study Type
Contacts and Locations
Study Locations
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New York
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New York City, New York, United States, 10021
- Weill Medical College of Cornell University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients that meet the American-European Consensus Conference criteria for ARDS [(1) Widespread pulmonary infiltrates; (2) Pulmonary capillary wedge pressure 18 mmHg; (3) PaOz/FiO; ratio 200; (4) compatible history], or acute lung injury [same as ARDS, but PaOz/FiOz ratio 300], or are at increased risk for developing acute lung injury because of sepsis, pancreatitis, trauma, acid aspiration, radiation or chemotherapy-induced lung toxicity, and near drowning. Pulmonary edema is divided into two broad categories: hydrostatic or cardiogenic and increased-permeability or noncardiogenic edema12. Since ARDS is noncardiogenic in origin, patients with pulmonary edema due to congestive heart failure will serve as a control group.
- Inpatients that are endotracheally intubated.
- Patients that are able to provide informed consent or informed consent is granted by a family member or legal health care proxy.
- Males or females that are 18 years or older.
Exclusion Criteria:
- Individuals who are too hypoxemic for bronchoscopy to be performed safely. Patients requiring V\0z > 0.7 and/or PEEP 15 will be excluded.
2. If the patient will be unable to tolerate bronchoscopy because of severe
acidosis, tension pneumothorax, active bronchospasm, hemodynamically significant cardiac arrhythmia, or intractable shock as defined as the inability to maintain a mean arterial pressure 60 mmHg or severe uncorrectable bleeding diathesis (tendency) or as otherwise determined by the pulmonary physician.
3. Females who are pregnant will not be accepted into the study. 4. Patients with recent (48 hours) acute myocardial infraction will not be accepted into the study.
5. Patients with a history of adverse reactions to lidocaine will be not be accepted into the study. 6. Patients who lack capacity to give informed consent due to acute panic attack, "intensive care unit" psychosis or other psychologic dysfunction.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Robert J. Kaner, M.D., Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VEGF in ARDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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