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

Return to Study Synopsis

Spectral Medical INC

Study Investigators

  • PI: Michael Seneff, MD
  • Sub-I: Danielle Davison, MD
  • Sub-I: David Yamane, MD
  • Sub-I: Katrina Hawkins, MD


Study Objectives

  • 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.


Patient Population

Intensive Care Unit subjects with septic shock and endotoxemia [low, intermediate and high levels] as determined by EAA.


Inclusion Criteria

  • 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


Exclusion Criteria

  • 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).