Therapeutic Plasma Exchange in Septic Shock: A Pilot Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

March 31, 2027

Study Completion Date

December 31, 2027

Conditions
Septic Shock
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.

Trial Locations (11)

Unknown

RECRUITING

Foothills Medical Centre, Calgary

RECRUITING

Southern Health Campus, Calgary

RECRUITING

University of Alberta, Edmonton

RECRUITING

Hamilton Health Sciences - Juravinski, Hamilton

RECRUITING

St. Joseph's Hospital, Hamilton

RECRUITING

Ottawa Hospital, Ottawa

RECRUITING

St. Michael's Hospital, Toronto

RECRUITING

Universite Laval, Québec

R3E 0W2

RECRUITING

University of Manitoba, Winnipeg

K7L2X3

RECRUITING

Queen's University at Kingston, Kingston

H2X 0C1

RECRUITING

Centre Hospitalier de L'Université de Montréal (Chum),, Montreal

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Health Sciences Centre Foundation, Manitoba

OTHER

collaborator

McMaster University

OTHER

collaborator

University of Toronto

OTHER

lead

University of Manitoba

OTHER