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RECRUITING
NCT05093075
PHASE2

Therapeutic Plasma Exchange in Septic Shock: A Pilot Study

Sponsor: University of Manitoba

View on ClinicalTrials.gov

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

OTHER

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