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

• Status: Withdrawn
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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