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Role of Vascular Endothelial Growth Factor (VEGF) in Acute Lung Injury/Adult Respiratory Distress Syndrome (ARDS)

This study has been withdrawn prior to enrollment.
(Under the discretion of the PI the study has been withdrawn.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00319631
First Posted: April 27, 2006
Last Update Posted: January 30, 2017
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.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
Understanding the role VEGF plays in ARDS consequently provides an ideal opportunity to discover new therapies for ARDS.

Condition
Respiratory Distress Syndrome, Adult

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Role of Vascular Endothelial Growth Factor (VEGF) in Acute Lung Injury/Adult Respiratory Distress Syndrome (ARDS)

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Enrollment: 0
Actual Study Start Date: January 2006
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects for the study will be drawn from endotracheally intubated inpatients of The New York Presbyterian Hospital-Weill Cornell Medical Center diagnosed with ALI or ARDS or who are at risk for developing ARDS.
Criteria

Inclusion Criteria:

  1. 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.
  2. Inpatients that are endotracheally intubated.
  3. Patients that are able to provide informed consent or informed consent is granted by a family member or legal health care proxy.
  4. 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319631


Locations
United States, New York
Weill Medical College of Cornell University
New York City, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Robert J. Kaner, M.D. Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00319631     History of Changes
Other Study ID Numbers: VEGF in ARDS
First Submitted: April 27, 2006
First Posted: April 27, 2006
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Weill Medical College of Cornell University:
Respiratory Distress Syndrome, Adult

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Injury
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs