Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis
NCT ID: NCT04057872
Last Updated: 2025-10-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
17 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-10-21
Study Completion Date
2024-12-31
Brief Summary
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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.
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.
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Detailed Description
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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:
1. Reeves and colleagues attempted a multi-center Australian study but terminated enrollment after 22 adult and 8 children (28). The mean APACHEII scores for adults were 25.2. They aggressively exchanged 5 plasma volumes continuously over 36 hours using a combination of fresh frozen plasma (FFP) and albumin (1/4 ratio). Mortality was reported at 14 days. No data on ICU or hospital length of stay was provided. This trial reported significant decrease in certain inflammatory markers.
2. Busund's larger trail involved 106 adults and reported mortality at 28 days (25). They performed a single 30-40mls/kg exchange that could be repeated once if no clinical improvement was observed. The replacement used was FFP and albumin in a 1:1 ratio. Six episodes of transient hypotension and 1 allergic reaction to FFP was reported (the only trial to report adverse events). There was an encouraging trend towards improved survival (33% vs 53%) versus historical controls. No data on ICU or hospital length of stay was provided.
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
1. The incidence of sepsis has increased over 4 decades but no single pharmacological invention reduces mortality/morbidity.
2. A potential treatment that increases the chance of survival and recovery in patients with septic shock would be both beneficial to patients and help decrease medical costs from long term stays in the ICU.
3. The maximum tolerable dose of TPE in septic patients is unknown.
Study Objectives
Primary Objective: To evaluate the safety of the TPE intervention protocol within 24 hours of study criteria being met.
Secondary Objectives:
1. To evaluate preliminary efficacy of the TPE protocol.
2. To determine maximum tolerable dose of TPE in septic patients.
3. To record adverse events from TPE intervention.
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.
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:
1. Reeves and colleagues attempted a multi-center Australian study but terminated enrollment after 22 adult and 8 children (28). The mean APACHEII scores for adults were 25.2. They aggressively exchanged 5 plasma volumes continuously over 36 hours using a combination of fresh frozen plasma (FFP) and albumin (1/4 ratio). Mortality was reported at 14 days. No data on ICU or hospital length of stay was provided. This trial reported significant decrease in certain inflammatory markers.
2. Busund's larger trail involved 106 adults and reported mortality at 28 days (25). They performed a single 30-40mls/kg exchange that could be repeated once if no clinical improvement was observed. The replacement used was FFP and albumin in a 1:1 ratio. Six episodes of transient hypotension and 1 allergic reaction to FFP was reported (the only trial to report adverse events). There was an encouraging trend towards improved survival (33% vs 53%) versus historical controls. No data on ICU or hospital length of stay was provided.
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
1. The incidence of sepsis has increased over 4 decades but no single pharmacological invention reduces mortality/morbidity.
2. A potential treatment that increases the chance of survival and recovery in patients with septic shock would be both beneficial to patients and help decrease medical costs from long term stays in the ICU.
3. The maximum tolerable dose of TPE in septic patients is unknown.
Study Objectives
Primary Objective: To evaluate the safety of the TPE intervention protocol within 24 hours of study criteria being met.
Secondary Objectives:
1. To evaluate preliminary efficacy of the TPE protocol.
2. To determine maximum tolerable dose of TPE in septic patients.
3. To record adverse events from TPE intervention.
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.
Conditions
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Septic Shock
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Consecutive Adults patients with vasoplegic septic shock with at least 2 organ dysfunction will receive TPE
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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TPE in Septic Shock
The patients will undergo a dosing trial to determine safety and the most effective dose
Group Type
EXPERIMENTAL
Therapeutic plasma exchange
Intervention Type
PROCEDURE
The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, and/or Fresh frozen plasma
Interventions
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Therapeutic plasma exchange
The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, and/or Fresh frozen plasma
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
Exhibiting two of the four clinical signs of inflammation:
1. Core temperature \> 38oC or \< 36oC
2. Heart rate \> 90 beats per minute
3. Respiratory rate \> 20 breaths per minute, or PaCO2 \< 32 mmHg, or mechanical ventilation
4. White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils
We will further identify the subset with a hospital mortality in excess of 40%:
1. \>30 mls/kg fluid resuscitation
2. Noradrenaline \>0.1 ug/kg/min to maintain MAP\> 65mmHg for at least 4 consecutive hours and present at initiation of TPE
3. Lactate \>2 mmol/l.
1. Core temperature \> 38oC or \< 36oC
2. Heart rate \> 90 beats per minute
3. Respiratory rate \> 20 breaths per minute, or PaCO2 \< 32 mmHg, or mechanical ventilation
4. White cell count \> 12 x 109/L or \< 4 x 109/L or \> 10% immature neutrophils
We will further identify the subset with a hospital mortality in excess of 40%:
1. \>30 mls/kg fluid resuscitation
2. Noradrenaline \>0.1 ug/kg/min to maintain MAP\> 65mmHg for at least 4 consecutive hours and present at initiation of TPE
3. Lactate \>2 mmol/l.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Alberta Health Services, Calgary
OTHER
Sponsor Role
lead
Responsible Party
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Dr. George Alvarez
Intensivist, Department of Critical Care Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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George F Alvarez, MD
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Locations
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Peter Lougheed Centre
Calgary, Alberta, Canada
Site Status
South Health Campus
Calgary, Alberta, Canada
Site Status
Countries
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Canada
References
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Sarode R, Bandarenko N, Brecher ME, Kiss JE, Marques MB, Szczepiorkowski ZM, Winters JL. Thrombotic thrombocytopenic purpura: 2012 American Society for Apheresis (ASFA) consensus conference on classification, diagnosis, management, and future research. J Clin Apher. 2014 Jun;29(3):148-67. doi: 10.1002/jca.21302. Epub 2013 Oct 17.
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BACKGROUND
Reeves JH. A review of plasma exchange in sepsis. Blood Purif. 2002;20(3):282-8. doi: 10.1159/000047021.
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Zhou F, Peng Z, Murugan R, Kellum JA. Blood purification and mortality in sepsis: a meta-analysis of randomized trials. Crit Care Med. 2013 Sep;41(9):2209-20. doi: 10.1097/CCM.0b013e31828cf412.
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Scharfman WB, Tillotson JR, Taft EG, Wright E. Plasmapheresis for meningococcemia with disseminated intravascular coagulation. N Engl J Med. 1979 May 31;300(22):1277-8. No abstract available.
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Bjorvatn B, Bjertnaes L, Fadnes HO, Flaegstad T, Gutteberg TJ, Kristiansen BE, Pape J, Rekvig OP, Osterud B, Aanderud L. Meningococcal septicaemia treated with combined plasmapheresis and leucapheresis or with blood exchange. Br Med J (Clin Res Ed). 1984 Feb 11;288(6415):439-41. doi: 10.1136/bmj.288.6415.439.
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BACKGROUND
Lercari G, Paganini G, Malfanti L, Rolla D, Machi AM, Rizzo F, Cannella G, Valbonesi M. Apheresis for severe malaria complicated by cerebral malaria, acute respiratory distress syndrome, acute renal failure, and disseminated intravascular coagulation. J Clin Apher. 1992;7(2):93-6. doi: 10.1002/jca.2920070211.
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Gardlund B, Sjolin J, Nilsson A, Roll M, Wickerts CJ, Wikstrom B, Wretlind B. Plasmapheresis in the treatment of primary septic shock in humans. Scand J Infect Dis. 1993;25(6):757-61. doi: 10.3109/00365549309008575.
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BACKGROUND
Busund R, Koukline V, Utrobin U, Nedashkovsky E. Plasmapheresis in severe sepsis and septic shock: a prospective, randomised, controlled trial. Intensive Care Med. 2002 Oct;28(10):1434-9. doi: 10.1007/s00134-002-1410-7. Epub 2002 Jul 23.
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Long EJ, Taylor A, Delzoppo C, Shann F, Pearson G, Buckley D, Butt W. A randomised controlled trial of plasma filtration in severe paediatric sepsis. Crit Care Resusc. 2013 Sep;15(3):198-204.
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Nguyen TC, Han YY, Kiss JE, Hall MW, Hassett AC, Jaffe R, Orr RA, Janosky J, Carcillo JA. Intensive plasma exchange increases a disintegrin and metalloprotease with thrombospondin motifs-13 activity and reverses organ dysfunction in children with thrombocytopenia-associated multiple organ failure. Crit Care Med. 2008 Oct;36(10):2878-87. doi: 10.1097/ccm.0b013e318186aa49.
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BACKGROUND
Reeves JH, Butt WW, Shann F, Layton JE, Stewart A, Waring PM, Presneill JJ. Continuous plasmafiltration in sepsis syndrome. Plasmafiltration in Sepsis Study Group. Crit Care Med. 1999 Oct;27(10):2096-104. doi: 10.1097/00003246-199910000-00003.
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BACKGROUND
Knaup H, Stahl K, Schmidt BMW, Idowu TO, Busch M, Wiesner O, Welte T, Haller H, Kielstein JT, Hoeper MM, David S. Early therapeutic plasma exchange in septic shock: a prospective open-label nonrandomized pilot study focusing on safety, hemodynamics, vascular barrier function, and biologic markers. Crit Care. 2018 Oct 30;22(1):285. doi: 10.1186/s13054-018-2220-9.
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BACKGROUND
Szczepiorkowski ZM, Winters JL, Bandarenko N, Kim HC, Linenberger ML, Marques MB, Sarode R, Schwartz J, Weinstein R, Shaz BH; Apheresis Applications Committee of the American Society for Apheresis. Guidelines on the use of therapeutic apheresis in clinical practice--evidence-based approach from the Apheresis Applications Committee of the American Society for Apheresis. J Clin Apher. 2010;25(3):83-177. doi: 10.1002/jca.20240.
Reference Type
BACKGROUND
Other Identifiers
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REB19-1157
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA