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Therapeutic Plasma Exchange in Septic Shock: A Pilot Study
Sponsor: University of Manitoba
Summary
The 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.
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-06-01
Completion Date
2027-12
Last Updated
2025-08-17
Healthy Volunteers
No
Conditions
Interventions
Therapeutic Plasma Exchange
TPE procedures will be performed using a Spectra Optia ® apheresis machine (Terumo BCT, Lakewood, USA) according to usual-care procedures for apheresis. Venous access for the TPE procedures will be obtained through a double lumen dialysis catheter to provide adequate flow rates required for TPE. Regional citrate anticoagulation will be used for anticoagulation within the apheresis circuit. One to two grams of calcium chloride will be infused as per standard during TPE to prevent symptomatic hypocalcemia. Plasma volume will be calculated as per a standard formula whereby estimated plasma volume (in liters) = 0.07 x weight (kg) x (1 - hematocrit). In patients on dialysis, dialysis will be interrupted for the duration of the procedure. Antibiotics will be given after TPE to avoid clearance of the antibiotics. On the first day of TPE, a repeat dose of antibiotics will be administered after completion of TPE. Nurse clinicians trained in TPE will perform the TPE procedures.
Locations (11)
Foothills Medical Centre
Calgary, Alberta, Canada
Southern Health Campus
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Hamilton Health Sciences - Juravinski
Hamilton, Ontario, Canada
St. Joseph's Hospital
Hamilton, Ontario, Canada
Queen's University at Kingston
Kingston, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre Hospitalier de L'Université de Montréal (Chum),
Montreal, Quebec, Canada
Universite Laval
Québec, Quebec, Canada