Therapeutic plasma exchange for patients with septic shock

Therapeutic Plasma Exchange in Septic Shock: A Pilot Study

This study is testing if a special blood treatment called plasma exchange can help people with septic shock feel better compared to the usual care they receive.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: University of Manitoba (Academic / other)
• Locations: 11 sites (Calgary, Alberta and 10 other locations)
• Trial ID: NCT05093075 on ClinicalTrials.gov

What this trial studies

This pilot trial aims to evaluate the feasibility of therapeutic plasma exchange compared to standard care in patients suffering from septic shock. Participants will undergo a plasma exchange procedure daily until they no longer require vasopressors, experience death, or complete a maximum of five treatments. The study will monitor various health parameters, including coagulopathy and adverse reactions related to the treatment. The control group will receive standard septic shock management as per established guidelines.

Who should consider this trial

Good fit: Ideal candidates are ICU patients aged 16 and older with refractory hypotension and at least one additional organ dysfunction.

Not a fit: Patients who do not meet the inclusion criteria, such as those without refractory hypotension or additional organ dysfunction, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve outcomes for patients with septic shock by potentially stabilizing their condition more effectively than standard treatments.

How similar studies have performed: While this approach is novel in the context of septic shock, similar studies in other conditions have shown promise with therapeutic plasma exchange.

Eligibility 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 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

Where this trial is running

Calgary, Alberta and 10 other locations

• Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
• Southern Health Campus — Calgary, Alberta, Canada (Recruiting)
• University of Alberta — Edmonton, Alberta, Canada (Recruiting)
• University of Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
• Hamilton Health Sciences - Juravinski — Hamilton, Ontario, Canada (Recruiting)
• St. Joseph's Hospital — Hamilton, Ontario, Canada (Recruiting)
• Queen's University at Kingston — Kingston, Ontario, Canada (Recruiting)
• Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
• St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
• Centre Hospitalier de L'Université de Montréal (Chum), — Montreal, Quebec, Canada (Recruiting)
• Universite Laval — Québec, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Ryan Zarychanski, MD, MSc — University of Manitoba
• Study coordinator: Emily Rimmer, MD, MSc

Conditions Septic Shock; Sepsis