NCT05093075 Therapeutic Plasma Exchange in Septic Shock: A Pilot Study
| NCT ID | NCT05093075 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Manitoba |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2023-06-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Ryan Zarychanski, MD, MSc
PRINCIPAL INVESTIGATOR
University of Manitoba
Frequently Asked Questions
Who can join the NCT05093075 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05093075 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05093075 currently recruiting?
Yes, NCT05093075 is actively recruiting participants. Contact the research team at erimmer@cancercare.mb.ca for enrollment information.
Where is the NCT05093075 trial being conducted?
This trial is being conducted at Calgary, Canada, Calgary, Canada, Edmonton, Canada, Winnipeg, Canada and 7 additional locations.
Who is sponsoring the NCT05093075 clinical trial?
NCT05093075 is sponsored by University of Manitoba. The principal investigator is Ryan Zarychanski, MD, MSc at University of Manitoba. The trial plans to enroll 80 participants.