Status:
RECRUITING
Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Stem Cell Network
Conditions:
Septic Shock
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MS...
Detailed Description
Septic shock is a devastating illness and the most severe form of infection seen in the intensive care unit (ICU). It is characterized by cardiovascular collapse, failure of organs and is common with ...
Eligibility Criteria
Inclusion
- A participant must meet all the following inclusion criteria at time of randomization to be eligible:
- At least 18 years of age AND
- Requirement for admission to the intensive care unit AND
- Index admission to the intensive care unit AND
- Cardiovascular organ failure for at least 1 consecutive hour defined by the requirement of at least 5 mcg/min of norepinephrine or 100 mcg/min of phenylephrine or 0.03 U/min vasopressin AND
- Clinician impression that cardiovascular organ failure is related to infection AND
- There is at least 1 other acute organ failure according to modified individual Sequential Organ Failure Assessment Scores within 24 hours of meeting Cardiovascular organ failure defined by:
- Respiratory failure: invasive or non-invasive mechanical ventilation with a positive end expiratory pressure (PEEP) \>/= 5 cm H2O and a partial pressure of oxygen/fractional inspired oxygen concentration (P/F ratio \</= 200), OR high-flow nasal canula oxygen therapy (minimum total flow rate of 30 lpm and 40% FiO2); OR
- Hematological failure: platelet count of \</= 100 X 10\^9/L OR
- Acute kidney injury: acute renal insufficiency with a creatinine of \>/= 200 umol/L, or the requirement for new renal replacement therapy, or for participants with known chronic renal failure but not on dialysis, a 50% increase in their baseline creatinine concentration OR
- Organ hypoperfusion: a lactate \>/= 4 mmol/L
- Acute organ failures that meet eligibility criteria must not have been present for greater than 48 hours prior to meeting the eligibility criteria.
Exclusion
- Patients will be excluded if they have at least one of the following at time of randomization:
- Another form of shock (cardiogenic, hypovolemic, obstructive) OR
- History of known chronic pulmonary hypertension with a WHO functional class of IV OR
- History of severe chronic pulmonary disease requiring home oxygen OR
- History of severe chronic cardiac disease including congestive heart failure or valvular dysfunction with a New York Heart Association Functional class IV or severe chronic ischemic heart disease with a Canadian Cardiovascular Society angina class score IV OR
- History of severe chronic liver disease (Child-Pugh Class C or model for end stage liver disease (MELD) Score \>= 15) OR
- Malignancy in previous 1 year (excluding resolved non-melanoma skin cancer) OR
- Treating physician impression that death is imminent within the 12 hours after meeting eligibility criteria OR
- Pregnant or lactating OR
- Family or patient not committed to aggressive care
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT05969275
Start Date
February 14 2024
End Date
March 31 2027
Last Update
December 5 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ottawa Hospital (General Campus)
Ottawa, Ontario, Canada, K1H 8L6
2
The Ottawa Hospital (Civic Campus)
Ottawa, Ontario, Canada, K1Y 4E9