Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT01314066
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01314066
Study Brief:
Protocol Section:
NCT01314066