NCT00319631

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

11 years

First QC Date

April 27, 2006

Last Update Submit

January 27, 2017

Conditions

Keywords

Respiratory Distress Syndrome, Adult

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Individuals who are too hypoxemic for bronchoscopy to be performed safely. Patients requiring V\\0z \> 0.7 and/or PEEP 15 will be excluded.
  • \. 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.
  • \. 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.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Robert J. Kaner, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations