Pilot Study of Bevacizumab (Avastin) in Patients With Septic Shock

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Septic Shock

In brief

The purpose of this study is to perform a pilot study to assess the potential use of Bevacizumab (a vascular endothelial growth factor (VEGF) inhibitor) in sepsis.

Key facts

Study ID

NCT01063010

Run by

Beth Israel Deaconess Medical Center

People needed

0

Starts

2010-02-01

Expected to finish

2015-01-01

Last updated by the study team

2024-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible patients are all adult patients, age > 18, who meet the following inclusion criteria:
• Evidence of infection a. temperature > 100.4F or < 97.0F of non-environmental causes, pneumonia as determined by the presence of an infiltrate on chest x-ray, a non-contaminated urinalysis with > 10 WBC or a urine dip-stick positive for leukocyte esterase, an abdominal CT scan yielding the diagnosis of an intra-abdominal etiology, skin/soft tissue infection on clinical exam.
• Two or more SIRS criteria a. tachycardia (HR>90) b. tachypnea (RR>20) or hypoxia (oxygen saturation<90%) c. hyperthermia >100.4 F (38C) or hypothermia <96F (35.5C) d. leukocytosis WBC> 15,000 cells/mm3 or bands>10%]
• Septic shock a. persistent hypotension (SBP < 90mmHg) after an initial 20-30 cc/kg fluid challenge, or the need for vasopressors for at least 1 hour in order to maintain a systolic blood pressure >90 mmHG; enrollment within 48 hours of meeting eligibility criteria.

You may not qualify if…

• Disease-Specific Exclusions:
• Inability to obtain written informed consent from the patient or an appropriate designee General Medical Exclusions
• Life expectancy of less than 12 weeks
• Bevacizumab-Specific Exclusions:
• Inadequately controlled hypertension
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
• History of myocardial infarction or unstable angina within 12 months prior to Day 1
• History of stroke or transient ischemic attack within 12 months prior to Day 1
• Known CNS malignancy, except for treated brain metastasis
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
• History of hemoptysis within 1 month prior to Day 1
• History of chronic bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
• Serious, non-healing wound, active ulcer, or untreated bone fracture
• Proteinuria at screening
• Known hypersensitivity to any component of bevacizumab
• Pregnancy or lactation
• Any clotting abnormalities or a history of deep venous thrombosis or pulmonary embolus.

Where it is running

• Beth Israel Medical Center — Boston, Massachusetts, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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