Cellular Immunotherapy for Septic Shock: A Phase I Trial (CISS)

Inclusion Criteria:

A participant must meet all 5 inclusion criteria to be eligible:

1. Admission to the Ottawa Hospital Intensive Care Unit
2. Receipt of appropriate broad spectrum antibiotics for the suspected/confirmed infectious source and adequate source control according to the opinion of the treating critical care physician

3. Within 24 hours of admission to the ICU, receipt of reasonable levels of fluid administration and resuscitation as indicated by:

   • a central venous pressure of at least 8 mm Hg AND
   • a central venous oxygen saturation of at least 70%.
4. Cardiovascular failure that is present within the first 24 hours of admission to the ICU and that is present for at least 4 consecutive hours AND
5. Deterioration or lack of improvement in at least 1 additional organ function, or organ hypoperfusion, as defined by the modified Multiple Organ Dysfunction Score (MODS). Criteria for organ dysfunction or organ hypoperfusion must be met within the first 24 hours of ICU admission

Exclusion Criteria:

1. Another form of shock (cardiogenic, hypovolemic, obstructive) that is considered by the treating critical care physician as the dominant cause of shock
2. History of known pulmonary hypertension with a WHO functional class of III or IV
3. History of severe pulmonary disease requiring home oxygen
4. History of severe cardiac disease with a New York Heart Association Functional Class of III or IV, or severe ischemic heart disease with a Canadian Cardiovascular Society angina class score of III or IV
5. History of severe liver disease (Child class C)
6. Malignancy in the previous 2 years (excluding resolved non-melanoma skin cancer).
7. Chronic immune suppression
8. History of anaphylaxis
9. Pregnant or lactating
10. Enrolment in another interventional study
11. Family, participant, or physician not committed to aggressive care
12. Less than 18 years of age