A Phase 2 interventional study of Bevacizumab and Placebo in Severe Sepsis and Acute Respiratory Distress Syndrome, sponsored by Weill Medical College of Cornell University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2016-05-03.
Sponsored by Weill Medical College of Cornell University · Phase 2, Interventional, and Prevention
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.
Acute respiratory distress syndrome (ARDS) is the most extreme form of acute lung injury (ALI) that results in a loss of lung function and structure. Vascular endothelial growth factor (VEGF), a protein critical for lung development that is found in the thin layer of liquid lining the inner surface of the lung air sacs, is believed to play a key role in the development of ARDS. During ARDS/ALI, VEGF markedly increases the permeability of the cells lining the inner surface of blood vessels in the lungs, which leads to an accumulation of fluid in the lungs (pulmonary edema), a characteristic of ARDS/ALI. Thus, anti-VEGF therapies offer a unique approach to treat this potentially fatal disorder. Bevacizumab (Avastin ®), an anti-VEGF medication, has been shown to be effective in inhibiting pulmonary edema caused by VEGF over-expression in an animal model.
This study will establish the usefulness and effectiveness of a singe dose of Bevacizumab administered intravenously (through the vein) in reducing the incidence of ARDS in individuals with severe sepsis (a condition characterized by an inflammatory response by the immune system throughout the whole body caused by infection) who are at high risk for the development of ARDS. All study participants will be randomized to receive placebo, bevacizumab 5 mg/kg or bevacizumab 10 mg/kg as a single intravenous dose in a double-blinded fashion in addition to traditional sepsis treatment.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
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Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
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Exclusion Criteria:
Receive drug solution as a single dose. Treatment will be given as 90 minute IV infusion.
Drug: Bevacizumab
Receive drug solution as a single dose. Treatment will be given as 90 minute IV infusion.
Drug: Bevacizumab
In addition to receiving the best standard supportive care for both diagnosis and treatment for individuals diagnosed with severe sepsis, they will receive an IV saline solution.
Drug: Placebo
Patients receiving drug will receive it as a single dose. Treatment will be given as 90-minute IV infusion. The patient will either receive Bevacizumab at 5 mg/kg OR Bevacizumab at 10 mg/kg.
Also known as: Avastin
Patients assigned to placebo-control group will receive a single dose of saline solution as a 90 minute IV infusion
Proportion of individuals progressing to meet RDS criteria as defined by the American- European ARDS consensus conference and as used by ARDSnet.
Time frame: Day 28
Ventilator-free days to Day 28
Time frame: Day 28
28 day all-cause mortality
Time frame: Day 28
Proportion of subjects progressing to acute lung injury (who do not meet the definition at randomization)
Time frame: Day 28
Worst PaO2/FiO2 ratio recorded following enrollment
Time frame: Day 3 and 28
Change in PaO2/FiO2 ratio between Day 0 to Day 3
Time frame: Day 0 and Day 3
Change from baseline in number of non-lung organ failures using the Multi-Organ Dysfunction (MOD) score and Sepsis Organ Failure Assessment (SOFA) score
Time frame: Day 0, Day 28
Proportion of subjects surviving to hospital discharge
Time frame: Hospital Discharge Day
Vasopressor-free days
Time frame: Day 28
Reversal of shock if present at randomization.
Time frame: Day 28
Plan to share: Undecided
This study is withdrawn, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University