Recruiting
Phase 2

Therapeutic Plasma Exchange

Sponsor:

University of Manitoba

Code:

NCT05093075

Conditions

Septic Shock

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Therapeutic Plasma Exchange

Study Details

Brief 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.

Conditions

Septic Shock

Study ID

NCT05093075

Start date

Jun 1, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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 48 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. Capacity to initiate plasma exchange with 48 hours of vasopressor initiation.
4. At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following at the time of enrollment:

1. Creatinine ≥1.5x the known baseline creatinine within 7 days, or ≥ 26.5 µmol/l increase in 48 hours,
2. Need for invasive mechanical ventilation or a P/F ratio <250
3. Platelets <100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrollment
4. Arterial pH < 7.30 or base deficit > 5 mmol/L in association with a lactate >/= to 3.0 mmol/L

45\. Known or suspected infection

2.4.3 Exclusion criteria

We will exclude patients who have any one of the following criteria at the time of enrollment:

1. Consent declined (refusal from patient, SDM, or physician)
2. Clinically apparent alternate causes for shock (cardiogenic, hemorrhagic, obstructive, neurogenic or anaphylactic)
3. Terminal illness with a life expectancy of less than 3 months
4. Are pregnant

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Participants randomized to the Treatment Arm will received 1.0 plasma exchanges daily until discontinuation of vasopressors, death or to a maximum of 5 daily treatments. Solvent detergent plasma (SDP) or frozen plasma (FP) depending on availability will be used as the replacement fluid.

no intervention: Standard of Care Arm

Participants randomized to the Control Arm will receive standard of care for the treatment of septic shock in accordance with local practice and informed by national and international guidelines.

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.

Primary outcome measure

  • Assess the feasibility of a large, multicenter trial of TPE in patients with septic shock [ Time Frame: 18 months for enrollment ]

Central Contacts and Locations

Central contacts

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Principal Investigator:

Brent Winston, MD

Southern Health Campus

Recruiting

Calgary, Alberta, Canada

Contacts

Principal Investigator:

George Alvarez, MD

University of Alberta

Recruiting

Edmonton, Alberta, Canada

Contacts

Caylin Chadwick

caylin.chadwick@ahs.ca

Principal Investigator:

Sean Bagshaw, MD

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0W2

Contacts

Hamilton Health Sciences - Juravinski

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Bram Rochwerg, MD

St. Joseph's Hospital

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Deborah Cook, MD

Queen's University at Kingston

Recruiting

Kingston, Ontario, Canada, K7L2X3

Contacts

Principal Investigator:

Gordon Boyd

Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Pieter Norgaard

pnorgaard@ohri.ca

Principal Investigator:

Lauralyn McIntyre, MD

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

Katerina Pavenski, MD

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

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Principal Investigator:

Han Ting Wang

Universite Laval

Recruiting

Québec, Quebec, Canada

Principal Investigator:

Alexis Turgeon, MD

More Information

Sponsor

University of Manitoba

Last update posted

Aug 17, 2025

Last verified

Aug, 2025

Keywords

  • Sepsis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-08-17.