Therapeutic plasma exchange for patients with septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Ryan Zarychanski, MD, MSc — University of Manitoba
• Study coordinator: Emily Rimmer, MD, MSc
• Email: erimmer@cancercare.mb.ca
• Phone: 204-787-2128

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adjunctive Fludrocortisone in Septic Shock on Hydrocortisone

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• Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter

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• Personalized Fluid Resuscitation in the Emergency Department

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• Discordance between capillary refill time and oxygen use in septic shock

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• Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock

  This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.

  Recruiting Alexandria University · Alexandria, Alexandria Governorate · NCT07716956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.