Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01314066
Recruitment Status : Withdrawn (No funding)
First Posted : March 14, 2011
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE July 28, 2010
First Posted Date  ICMJE March 14, 2011
Last Update Posted Date May 3, 2016
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Bevacizumab in Preventing Acute Respiratory Distress Syndrome (ARDS)
Official Title  ICMJE Efficacy of Bevacizumab in Preventing Acute Respiratory Distress Syndrome (ARDS)
Brief 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Severe Sepsis
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • Drug: Bevacizumab
    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.
    Other Name: Avastin
  • Drug: Placebo
    Patients assigned to placebo-control group will receive a single dose of saline solution as a 90 minute IV infusion
Study Arms  ICMJE
  • Experimental: Bevacizumab 5 mg/kg
    Receive drug solution as a single dose. Treatment will be given as 90 minute IV infusion.
    Intervention: Drug: Bevacizumab
  • Experimental: Bevacizumab at 10 mg/kg
    Receive drug solution as a single dose. Treatment will be given as 90 minute IV infusion.
    Intervention: Drug: Bevacizumab
  • Placebo Comparator: Placebo
    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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 29, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2011)
75
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01314066
Other Study ID Numbers  ICMJE IRB Protocol #0907010498
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Kaner, MD Weill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP