Clinical trial NCT00319631: Role of Vascular Endothelial Growth Factor (VEGF) in Acute Lung Injury/Adult Respiratory Distress Syndrome (ARDS)
Official title: Role of Vascular Endothelial Growth Factor (VEGF) in Acute Lung Injury/Adult Respiratory Distress Syndrome (ARDS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Respiratory Distress Syndrome, Adult
Keywords: Respiratory Distress Syndrome, Adult
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2006-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: Understanding the role VEGF plays in ARDS consequently provides an ideal opportunity to discover new therapies for ARDS.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York City
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Robert J. Kaner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: