Skip to content

Therapeutic Plasma Exchange in Septic Shock: a Pilot Study

Septic Shock

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.

null

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 Alberta
Edmonton, Alberta
Canada

Contact Study Team

Backup Contact

Sean Bagshaw, MD

Primary Contact

Nadia Baig

Ottawa Hospital
Ottawa Hospital
Ottawa, Ontario
Canada

Contact Study Team

Backup Contact

Lauralyn McIntyre, MD

Primary Contact

Irene Watpool

Southern Health Campus
Southern Health Campus
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Theophany Eystathioy

Backup Contact

George Alvarez, MD

St. Joseph's Hospital
St. Joseph's Hospital
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

France Clarke

Backup Contact

Deborah Cook, MD

University of Manitoba
University of Manitoba
Winnipeg, Manitoba
Canada

Contact Study Team

Primary Contact

Chantale Pineau, MA

[email protected]
2042353223
St. Michael's Hospital
St. Michael's Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Amy Moorehead

Backup Contact

Katerina Pavenski, MD

Foothills Medical Centre
Foothills Medical Centre
Calgary, Alberta
Canada

Contact Study Team

Backup Contact

Brent Winston, MD

Primary Contact

Theophany Eystathioy

Hamilton Health Sciences - Juravinski
Hamilton Health Sciences - Juravinski
Hamilton, Ontario
Canada

Contact Study Team

Backup Contact

Bram Rochwerg, MD

Primary Contact

Tina Millen

Universite Laval
Universite Laval
Quebec City, Quebec
Canada

Contact Study Team

Backup Contact

Alexis Turgeon, MD

Primary Contact

Stephanie Massana

Study Sponsored By
University of Manitoba
Participants Required
More Information
Study ID: NCT05093075