A Phase 1 interventional study of Therapeutic plasma exchange in Septic Shock, sponsored by Alberta Health Services, Calgary. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Alberta Health Services, Calgary · Phase 1, Interventional, and Other
Among 38 studies in Shock, Septic with a site in Canada — 7 open to participants now, 7 under way, 2 of them phase 3. Shock, Septic · Canada.
Among the 38 studies in Shock, Septic with a site in Canada, this one is the 23rd largest by enrollment of the 26 interventional ones that give a count, is one of 2 that started in 2020, is one of 3 in phase 1, and was the 30th registered.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
Browse Shock, Septic studies →7 of the 38 studies in Shock, Septic with a site in Canada are open now. Recruiting first, the newest first:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Sites in Canada
Ottawa Hospital Research Institute · Sites in Canada
University of Manitoba · Sites in Canada
Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Sites in Canada
Jerry Zimmerman · Sites in Canada, United States, Brazil and 7 more countries
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
38 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 10 · Phase 4 2
First in 2003; this study’s year is marked. 2 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Median enrollment 129 across the 26 interventional studies, 328 across the 12 observational. Of the 27 that completed or were terminated, 6 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 38 have an industry lead sponsor. The 10 most frequent:
Alberta Health Services, Calgary is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Alberta Health Services, Calgary has 1 study filed under Shock, Septic — fewer than ten, so there is no comparison to draw.
2 of the studies in Shock, Septic with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06124092St. Justine's HospitalOutcomes of Children After Hospitalization in Intensive Care Unit | 2027-03 |
| NCT05093075University of ManitobaTherapeutic Plasma Exchange in Septic Shock: A Pilot Study | 2027-03 |
Among the 38 studies in Shock, Septic with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The incidence of sepsis (severe infection) has increased over the last four decades. Severe sepsis and septic shock are among the leading causes of death for patients admitted to critical care units with mortality ranging from 20-70% depending on totality of organ dysfunction. Outside of antibiotics and good bedside care, little has changed in the management of this life-threatening problem.
Therapeutic plasma exchange (TPE) involves the separation of plasma from whole blood. The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, blood products or a combination thereof.
The primary objective of this study is to evaluate the safety of the TPE intervention protocol within 24 hours of study criteria being met. TPE is now a well-established program at the South Health Campus for neuro-muscular disorders. Since starting in May 2018, the investigators have performed over 150 runs making the SHC ICU one of the most experienced centers in Canada.
Background
The incidence of sepsis has increased over the last four decades (1). Sepsis is a life-threatening condition that arises when the body's response to an infection injures its own tissues and organs. Severe sepsis and septic shock are among the leading causes of death for patients admitted to critical care units with mortality ranging from 20-70% depending on totality of organ dysfunction (2, 3). The literature is replete with initial promising phase 2 therapies failing in definitive randomized trails (4-8). In fact, a recent systematic review concluded that no evidence exists for any pharmacologic intervention that has consistently reduced mortality in critically ill patients (9). This is both surprising and frustrating for the author. The most recent guidelines have tried to redefine sepsis as a 'syndrome' since neither validated criterion nor do standard diagnostic tests exist (10). The authors argue that sepsis should be viewed as organ dysfunction caused by a dysregulated or non-homeostatic host response. Most of the clinical manifestations of severe infections are caused by an intense, generalized inflammatory response in the host mediated by a multitude of interrelated cellular and humoral factors (3).
Plasmapheresis or therapeutic plasma exchange (TPE) involves the separation of plasma from whole blood. The removed plasma is 'exchanged or replaced' with crystalloids, albumin, fresh frozen plasma or a combination thereof. TPE use is well established in many neurological disorders including Guillain-Barre syndrome (11), Myasthenia Gravis (12, 13) and antibody mediated syndromes(14, 15). It is considered the standard of care for thrombotic thrombocytopenic purpura (TTP) (16, 17). The rationale for the use of TPE in sepsis, a non-selective intervention, is to remove multiple toxic mediators including endotoxins, activated complement, pro-inflammatory cytokines and pro-coagulant factors (18, 19). If fresh-frozen plasma is used as replacement fluid, consumed plasma factors are substituted, thereby possibly restoring the opsonic capacity and improving the coagulation abnormalities and microcirculation.
Plasma exchange has been reported since the late 1970s as a potential adjunctive or salvage therapy in severe sepsis in both pediatric and adult patients (20-24). These case reports, retrospective reviews and observational studies suggest a survival advantage when compared to historical controls. However, the obvious bias limits any meaningful interpretation. A literature review found only 4 studies with any attempt at randomization. One study enrolled only adults (25), two were exclusively pediatric patients (26, 27) and one study involved both adults and children (28). Excluding the pediatric studies, the adult protocols had few similarities:
A more recent German pilot study tried to evaluate the safety and feasibility of enrollment within 12 hours of shock for a proposed randomized controlled trial (RCT) (29). The inclusion criteria were simple: (a) Current sepsis-3 definitions; noradrenaline dose >0.4ug/kg/min despite >30mls/kg of crystalloid; (b) Less than 12 hours of vasopressor support. They performed a single 1.2x plasma exchange using entirely FFP. The major findings were significantly less vasopressor support, fluid balance and a decline in plasma concentrations of pro-inflammatory mediators. The "sustained -responders" mortality was 43% vs 77% of non-responders, but the small numbers prevented statistical significance.
The use of plasma exchange in severe sepsis is graded by the American Society for Apheresis as category III with grade 2C indications, indicating that there is a lack of reliable trials to support TPE use in the condition (30). The purpose of this phase 1 clinical trial is to assess the safety of using plasma exchange in critically ill adult patients with septic shock. TPE is now a well-established program at the South Health Campus (SHC) for neuro-muscular disorders. Since starting in May 2018, we have performed over 240 runs in 43 patients making the SHC ICU the most experienced TPE center in Canada in the past 2 years. One plasma volume is currently the standard dose used safely in patients with neuro-muscular disorders at SHC.
Justification of Research
Study Objectives
Primary Objective: To evaluate the safety of the TPE intervention protocol within 24 hours of study criteria being met.
Secondary Objectives:
Hypothesis
It is hypothesized that TPE will be safe for use in patients with septic shock. We will determine the maximum tolerable dose via a dose escalation study.
Inclusion Criteria Adult patients (age ≥18) with a documented or strong clinical suspicion of infection that meets the definition of septic shock as per the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Exhibiting two of the four clinical signs of inflammation:
We will further identify the subset with a hospital mortality in excess of 40%:
Exclusion Criteria Patients will be excluded in cases where death is deemed inevitable or imminent during admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment.
The patients will undergo a dosing trial to determine safety and the most effective dose
Procedure: Therapeutic plasma exchange
The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, and/or Fresh frozen plasma
Adverse Events
Proportion of patients who experience at least 1 Adverse Event (AE)
Time frame: During course of ICU stay, could be up to 6 months
Discontinue TPE
Proportion of patients who discontinue TPE administration due to an AE
Time frame: During course of ICU stay, could be up to 6 months
Enrollment Rate
3\. Enrollment rate (patients screened, patients eligible, patients approached, patients enrolled)
Time frame: During course of ICU stay, could be up to 6 months
Protocol Completion
Protocol completion (patients who complete study protocol)
Time frame: During course of ICU stay, could be up to 6 months
Organ dysfunction
Resolution or worsening of organ dysfunction as per SOFA score
Time frame: During course of ICU stay, could be up to 6 months
Vasopressor support
Hours of vasopressor support
Time frame: During course of ICU stay, could be up to 6 months
Ventilator support
Days on ventilator if applicable
Time frame: During course of ICU stay, could be up to 6 months
Days in ICU
Days in ICU (censored to day ready for discharge)
Time frame: During course of ICU stay, could be up to 6 months
Mortality
Mortality
Time frame: During course of ICU stay, could be up to 6 months
RRT Required
Need for RRT
Time frame: During course of ICU stay, could be up to 6 months
Plan to share: Yes — Once the results have been analyzed and published the de-identified data will be made available to other researchers
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: The data will be made available once published. It will be made available for 5 years as per University of Calgary data storage protocol.
Ran from Oct 2020 to primary completion in Dec 2024, 50 months.
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Alberta Health Services, Calgary