The EDEN Project:
A Prospective, Multicenter, Observational Study to Assess Organ Failure Patterns in Endotoxemic Septic Shock
Protocol Number: SMI-NA014
Protocol Version: 1.0
Version Date: 05 Aug 2021
- PI: Michael Seneff, MD
- Sub-I: Danielle Davison, MD
- Sub-I: David Yamane, MD
- Sub-I: Katrina Hawkins, MD
- To compare SOFA and MODS as best fit into a model for ICU mortality prediction that includes EAA
- To determine survival to discharge truncated at 60 days as a function of organ failures and EAA
- To compare vasopressor doses over Days 0-3 in categories based on EAA
- To classify Acute Kidney Injury according to KDIGO criteria over Days 0-3
- To determine the patterns of organ failure over Days 0-3
- To classify patients using SENECA sepsis phenotypes [Seymour et al 2019] and compare to SOFA, MODS and EAA.
Intensive Care Unit subjects with septic shock and endotoxemia [low, intermediate and high levels] as determined by EAA.
- 18 years of age or older
- Hypotension requiring vasopressor support: Requirement for at least one of the vasopressors listed below, at the dose shown below, for at least 2 continuous hours and no more than 30 hours*
- Norepinephrine > 0.05mcg/kg/min
- Dopamine > 10 mcg/kg/min
- Phenylephrine > 0.4 mcg/kg/min
- Epinephrine > 0.05 mcg/kg/min
- Vasopressin > 0.03 units/min
- Vasopressin (any dose) in combination with another vasopressor listed above (at any dose)
- Documented or suspected infection defined as definitive or empiric intravenous antibiotic administration
- Lack of commitment for full medical support
- Inability to achieve or maintain a minimum mean arterial pressure (MAP) of ≥ 65mmHg despite vasopressor therapy and fluid resuscitation deemed adequate by the treating physician.
- There is clinical support for non-septic shock such as:
- Acute pulmonary embolus
- Transfusion reaction
- Acute coronary syndrome with low cardiac output
- Severe granulocytopenia (leukocyte count less than 500 cells/mm3).