Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Efficacy of Bevacizumab in Preventing Acute Respiratory Distress Syndrome (ARDS)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Recruiting |
NCT05535543 -
Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
|
||
Completed |
NCT04695392 -
Restore Resilience in Critically Ill Children
|
N/A | |
Terminated |
NCT04972318 -
Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia
|
N/A | |
Completed |
NCT04534569 -
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
|
||
Completed |
NCT04078984 -
Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.
|
||
Completed |
NCT04451291 -
Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure
|
N/A | |
Not yet recruiting |
NCT06254313 -
The Role of Cxcr4Hi neutrOPhils in InflueNza
|
||
Not yet recruiting |
NCT04798716 -
The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19
|
Phase 1/Phase 2 | |
Withdrawn |
NCT04909879 -
Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
|
Phase 2 | |
Terminated |
NCT02867228 -
Noninvasive Estimation of Work of Breathing
|
N/A | |
Not yet recruiting |
NCT02881385 -
Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation
|
N/A | |
Completed |
NCT02545621 -
A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
|
||
Withdrawn |
NCT02253667 -
Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients
|
N/A | |
Completed |
NCT02232841 -
Electrical Impedance Imaging of Patients on Mechanical Ventilation
|
N/A | |
Withdrawn |
NCT01927237 -
Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide
|
N/A | |
Completed |
NCT02889770 -
Dead Space Monitoring With Volumetric Capnography in ARDS Patients
|
N/A | |
Completed |
NCT01504893 -
Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia
|
N/A | |
Completed |
NCT01680783 -
Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure
|
N/A | |
Completed |
NCT02814994 -
Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients
|
N/A |