Therapeutic Plasma Exchange in Septic Shock: A Pilot Study

Who is this study for? Patients with Septic Shock
What treatments are being studied? Therapeutic Plasma Exchange
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• ≥ 16 years of age

• 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

• Capacity to initiate plasma exchange with 48 hours of vasopressor initiation.

• At least 1 other new organ dysfunction (in addition to refractory hypotension), defined by the following at the time of enrollment:

‣ Creatinine ≥1.5x the known baseline creatinine within 7 days, or ≥ 26.5 µmol/l increase in 48 hours,

⁃ Need for invasive mechanical ventilation or a P/F ratio \<250

⁃ Platelets \<100 x109/L, or a drop of 50 x109/L in the 3 days prior to enrollment

⁃ 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

Locations
Other Locations
Canada
Foothills Medical Centre
RECRUITING
Calgary
Southern Health Campus
RECRUITING
Calgary
University of Alberta
RECRUITING
Edmonton
Hamilton Health Sciences - Juravinski
RECRUITING
Hamilton
St. Joseph's Hospital
RECRUITING
Hamilton
Queen's University at Kingston
RECRUITING
Kingston
Centre Hospitalier de L'Université de Montréal (Chum),
RECRUITING
Montreal
Ottawa Hospital
RECRUITING
Ottawa
Universite Laval
RECRUITING
Québec
St. Michael's Hospital
RECRUITING
Toronto
University of Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Emily Rimmer, MD, MSc
erimmer@cancercare.mb.ca
204-787-2128
Backup
Chantale Pineau, BA
chantale.pineau@umanitoba.ca
204-235-3223
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Health Sciences Centre Foundation, Manitoba, University of Toronto, McMaster University
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov