Therapeutic Plasma Exchange in Septic Shock: a Pilot Study
Septic ShockThe investigators propose to conduct a multi-center randomized pilot feasibility trial comparing therapeutic plasma exchange to standard of care in patients diagnosed with septic shock.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
16 and up
Participation Criteria
Eligible patients must be admitted to an ICU and must meet all of the following inclusion criteria:
1. ≥ 16 years of age
2. Refractory hypotension documented within 24 hours prior to enrollment requiring the institution and ongoing use of vasopressor agents (phenylephrine, norepinephrine, vasopressin, epinephrine, midodrine or dopamine \>5 mcg/kg/min) at enrollment. Refractory hypotension is defined as a systolic blood pressure (SBP) less than 90 mmHg, or SBP less than 30 mmHg below baseline, or a mean arterial blood pressure less than 65 mmHg, despite adequate fluid resuscitation.
3. At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following at the time of enrollment:
a.) Creatinine ≥1.5x the known baseline creatinine, or ≥ 26.5 µmol/l increase, b.) Need for invasive mechanical ventilation or a P/F ratio \<250 c.) Platelets \<100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrollment d.) Arterial pH \< 7.30 or base deficit \> 5 mmol/L in association with a lactate \>/= to 3.0 mmol/L
4. Known or suspected infection
Exclusion Criteria:
Patients who have any one of the following criteria at the time of enrollment will be excluded:
1. Consent declined (refusal from patient, SDM, or physician)
2. Clinically apparent alternate causes for shock (cardiogenic, hemorrhagic, obstructive, neurogenic or anaphylactic)
3. Received vasopressor therapy for greater than 24 hours prior to enrollment
4. Terminal illness with a life expectancy of less than 3 months
5. Are pregnant
Study Location
University of Alberta
University of AlbertaEdmonton, Alberta
Canada
Contact Study Team
Sean Bagshaw, MD
Nadia Baig
Ottawa Hospital
Ottawa HospitalOttawa, Ontario
Canada
Contact Study Team
Lauralyn McIntyre, MD
Irene Watpool
Southern Health Campus
Southern Health CampusCalgary, Alberta
Canada
Contact Study Team
Theophany Eystathioy
George Alvarez, MD
St. Joseph's Hospital
St. Joseph's HospitalHamilton, Ontario
Canada
Contact Study Team
France Clarke
Deborah Cook, MD
University of Manitoba
University of ManitobaWinnipeg, Manitoba
Canada
Contact Study Team
St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
Contact Study Team
Amy Moorehead
Katerina Pavenski, MD
Foothills Medical Centre
Foothills Medical CentreCalgary, Alberta
Canada
Contact Study Team
Brent Winston, MD
Theophany Eystathioy
Hamilton Health Sciences - Juravinski
Hamilton Health Sciences - JuravinskiHamilton, Ontario
Canada
Contact Study Team
Bram Rochwerg, MD
Tina Millen
Universite Laval
Universite LavalQuebec City, Quebec
Canada
Contact Study Team
Alexis Turgeon, MD
Stephanie Massana
- Study Sponsored By
- University of Manitoba
- Participants Required
- More Information
- Study ID:
NCT05093075