Status:
COMPLETED
Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis
Lead Sponsor:
Alberta Health Services, Calgary
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The incidence of sepsis (severe infection) has increased over the last four decades. Severe sepsis and septic shock are among the leading causes of death for patients admitted to critical care units w...
Detailed Description
Background The incidence of sepsis has increased over the last four decades (1). Sepsis is a life-threatening condition that arises when the body's response to an infection injures its own tissues an...
Eligibility Criteria
Inclusion
- Inclusion Criteria Adult patients (age ≥18) with a documented or strong clinical suspicion of infection that meets the definition of septic shock as per the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
- Exhibiting two of the four clinical signs of inflammation:
- Core temperature \> 38oC or \< 36oC
- Heart rate \> 90 beats per minute
- Respiratory rate \> 20 breaths per minute, or PaCO2 \< 32 mmHg, or mechanical ventilation
- White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils
- We will further identify the subset with a hospital mortality in excess of 40%:
- \>30 mls/kg fluid resuscitation
- Noradrenaline \>0.1 ug/kg/min to maintain MAP\> 65mmHg for at least 4 consecutive hours and present at initiation of TPE
- Lactate \>2 mmol/l.
- Exclusion Criteria Patients will be excluded in cases where death is deemed inevitable or imminent during admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment.
Exclusion
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04057872
Start Date
October 21 2020
End Date
December 31 2024
Last Update
October 3 2025
Active Locations (2)
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1
Peter Lougheed Centre
Calgary, Alberta, Canada, T3M 1M4
2
South Health Campus
Calgary, Alberta, Canada, T3M 1M4