Efficacy of Bevacizumab in Preventing Acute Respiratory Distress Syndrome (ARDS)

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Severe Sepsis, Acute Respiratory Distress Syndrome

In brief

This study aims to test the effectiveness of a single intravenous (IV, through the vein) dose of the study drug, bevacizumab (Avastin), in preventing/reducing the development of Acute Respiratory Distress Syndrome (ARDS), in patients with severe sepsis, who are at high risk for developing ARDS. ARDS is a lung disease caused by a lung injury that leads to lung function impairment. The condition the patient has,severe sepsis, is a medical condition associated with an infection characterized as an immune system inflammatory response throughout your whole body that can lead to organ dysfunction, low blood pressure or insufficient blood flow to one or more of your organs.

Key facts

Study ID

NCT01314066

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2010-07-01

Expected to finish

2016-02-01

Last updated by the study team

2016-05-03

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical Diagnosis of Sepsis based on Modified Inflammatory Response Syndrome (SIRS) Criteria
• Evidence of a systemic response to infection
• 1 or more sepsis-induced organ failures modified from those as defined by Bernard, et al. (eg. PROWESS rhAPC study, NEJM)

You may not qualify if…

• Pregnant females
• Systolic blood pressure >170
• Diastolic blood pressure >110
• Preexisting proteinuria >0.3 g/24hr
• Known hypersensitivity to bevacizumab
• Subject or health care agent unable to provide written informed consent
• Diagnosis of lung cancer with active hemoptysis
• Patient not expected to survive 28 days independently of the septic episode due to severe underlying disease
• Presence of an advanced directive to withhold life-sustaining treatment
• Participation in another investigational study within 30 days of enrollment
• GI tract perforation and/or repair unless surgical incision is fully healed
• Any major surgery in the 28 days prior to enrollment
• Need for non-elective major surgery within 28 days
• Presence of enterocutaneous fistula (an abnormal connection between body cavities, in this case, from the intestine to the skin. Possible complication of surgery, where passageway progresses from intestine to surgery site to skin)
• Known or suspected tracheoesophageal fistula (an abnormal connection between the esophagus and the trachea)
• Current ICU stay of > 2 months prior to enrollment
• Need for therapeutic anti-coagulation

Where it is running

• Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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