search
Back to results

Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis

Primary Purpose

Septic Shock

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Therapeutic plasma exchange
Sponsored by
Alberta Health Services, Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Therapeutic Plasma Exchange (TPE), Septic Shock, Severe Sepsis, Albumin, Fresh Frozen Plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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.

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.

Sites / Locations

  • Peter Lougheed CentreRecruiting
  • South Health CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

TPE in Septic Shock

Reference Population

Arm Description

The patients in this arm will receive TPE

The patients will receive the standard of care for septic shock treatment

Outcomes

Primary Outcome Measures

Adverse Events
Proportion of patients who experience at least 1 Adverse Event (AE)
Discontinue TPE
Proportion of patients who discontinue TPE administration due to an AE
Enrollment Rate
3. Enrollment rate (patients screened, patients eligible, patients approached, patients enrolled)
Protocol Completion
Protocol completion (patients who complete study protocol)

Secondary Outcome Measures

Organ dysfunction
Resolution or worsening of organ dysfunction as per SOFA score
Vasopressor support
Hours of vasopressor support
Ventilator support
Days on ventilator if applicable
Days in ICU
Days in ICU (censored to day ready for discharge)
Mortality
Mortality
RRT Required
Need for RRT

Full Information

First Posted
August 2, 2019
Last Updated
July 18, 2023
Sponsor
Alberta Health Services, Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT04057872
Brief Title
Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis
Official Title
PILOT STUDY in the Use of Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Health Services, Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: 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. 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 The incidence of sepsis has increased over 4 decades but no single pharmacological invention reduces mortality/morbidity. 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. 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: To evaluate preliminary efficacy of the TPE protocol. To determine maximum tolerable dose of TPE in septic patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Therapeutic Plasma Exchange (TPE), Septic Shock, Severe Sepsis, Albumin, Fresh Frozen Plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Consecutive Adults patients with vasoplegic septic shock with at least 2 organ dysfunction will receive TPE
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TPE in Septic Shock
Arm Type
Active Comparator
Arm Description
The patients in this arm will receive TPE
Arm Title
Reference Population
Arm Type
No Intervention
Arm Description
The patients will receive the standard of care for septic shock treatment
Intervention Type
Procedure
Intervention Name(s)
Therapeutic plasma exchange
Intervention Description
The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, and/or Fresh frozen plasma
Primary Outcome Measure Information:
Title
Adverse Events
Description
Proportion of patients who experience at least 1 Adverse Event (AE)
Time Frame
During course of ICU stay, could be up to 6 months
Title
Discontinue TPE
Description
Proportion of patients who discontinue TPE administration due to an AE
Time Frame
During course of ICU stay, could be up to 6 months
Title
Enrollment Rate
Description
3. Enrollment rate (patients screened, patients eligible, patients approached, patients enrolled)
Time Frame
During course of ICU stay, could be up to 6 months
Title
Protocol Completion
Description
Protocol completion (patients who complete study protocol)
Time Frame
During course of ICU stay, could be up to 6 months
Secondary Outcome Measure Information:
Title
Organ dysfunction
Description
Resolution or worsening of organ dysfunction as per SOFA score
Time Frame
During course of ICU stay, could be up to 6 months
Title
Vasopressor support
Description
Hours of vasopressor support
Time Frame
During course of ICU stay, could be up to 6 months
Title
Ventilator support
Description
Days on ventilator if applicable
Time Frame
During course of ICU stay, could be up to 6 months
Title
Days in ICU
Description
Days in ICU (censored to day ready for discharge)
Time Frame
During course of ICU stay, could be up to 6 months
Title
Mortality
Description
Mortality
Time Frame
During course of ICU stay, could be up to 6 months
Title
RRT Required
Description
Need for RRT
Time Frame
During course of ICU stay, could be up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Core temperature > 38oC or < 36oC Heart rate > 90 beats per minute Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg, or mechanical ventilation 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%: >30 mls/kg fluid resuscitation Noradrenaline >0.1 ug/kg/min to maintain MAP> 65mmHg for at least 4 consecutive hours and present at initiation of TPE Lactate >2 mmol/l. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George F Alvarez, MD
Phone
403-956-2113
Ext
4039562113
Email
George.Alvarez@ahs.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Miranda Kavalench
Phone
403-956-2113
Ext
4039562113
Email
Miranda.Kavalench@ahs.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George F Alvarez, MD
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Alvarez
Phone
4039562113
Email
george.alvarez@ahs.ca
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Alvarez
Phone
4039562113
Email
george.alvarez@ahs.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the results have been analyzed and published the de-identified data will be made available to other researchers
IPD Sharing 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.
Citations:
PubMed Identifier
12700374
Citation
Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
Results Reference
background
PubMed Identifier
23984731
Citation
Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available. Erratum In: N Engl J Med. 2013 Nov 21;369(21):2069.
Results Reference
background
PubMed Identifier
28448952
Citation
Minasyan H. Sepsis and septic shock: Pathogenesis and treatment perspectives. J Crit Care. 2017 Aug;40:229-242. doi: 10.1016/j.jcrc.2017.04.015. Epub 2017 Apr 18.
Results Reference
background
PubMed Identifier
8196140
Citation
Fisher CJ Jr, Dhainaut JF, Opal SM, Pribble JP, Balk RA, Slotman GJ, Iberti TJ, Rackow EC, Shapiro MJ, Greenman RL, et al. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. Results from a randomized, double-blind, placebo-controlled trial. Phase III rhIL-1ra Sepsis Syndrome Study Group. JAMA. 1994 Jun 15;271(23):1836-43.
Results Reference
background
PubMed Identifier
8797612
Citation
Cohen J, Carlet J. INTERSEPT: an international, multicenter, placebo-controlled trial of monoclonal antibody to human tumor necrosis factor-alpha in patients with sepsis. International Sepsis Trial Study Group. Crit Care Med. 1996 Sep;24(9):1431-40. doi: 10.1097/00003246-199609000-00002.
Results Reference
background
PubMed Identifier
12851279
Citation
Abraham E, Reinhart K, Opal S, Demeyer I, Doig C, Rodriguez AL, Beale R, Svoboda P, Laterre PF, Simon S, Light B, Spapen H, Stone J, Seibert A, Peckelsen C, De Deyne C, Postier R, Pettila V, Sprung CL, Artigas A, Percell SR, Shu V, Zwingelstein C, Tobias J, Poole L, Stolzenbach JC, Creasey AA; OPTIMIST Trial Study Group. Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA. 2003 Jul 9;290(2):238-47. doi: 10.1001/jama.290.2.238.
Results Reference
background
PubMed Identifier
18037615
Citation
Afshari A, Wetterslev J, Brok J, Moller A. Antithrombin III in critically ill patients: systematic review with meta-analysis and trial sequential analysis. BMJ. 2007 Dec 15;335(7632):1248-51. doi: 10.1136/bmj.39398.682500.25. Epub 2007 Nov 23.
Results Reference
background
PubMed Identifier
22616830
Citation
Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gardlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD; PROWESS-SHOCK Study Group. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 May 31;366(22):2055-64. doi: 10.1056/NEJMoa1202290. Epub 2012 May 22.
Results Reference
background
PubMed Identifier
31567349
Citation
Santacruz CA, Pereira AJ, Celis E, Vincent JL. Which Multicenter Randomized Controlled Trials in Critical Care Medicine Have Shown Reduced Mortality? A Systematic Review. Crit Care Med. 2019 Dec;47(12):1680-1691. doi: 10.1097/CCM.0000000000004000.
Results Reference
background
PubMed Identifier
28101605
Citation
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
Results Reference
background
PubMed Identifier
1552913
Citation
van der Meche FG, Schmitz PI. A randomized trial comparing intravenous immune globulin and plasma exchange in Guillain-Barre syndrome. Dutch Guillain-Barre Study Group. N Engl J Med. 1992 Apr 23;326(17):1123-9. doi: 10.1056/NEJM199204233261705.
Results Reference
background
PubMed Identifier
21562253
Citation
Barth D, Nabavi Nouri M, Ng E, Nwe P, Bril V. Comparison of IVIg and PLEX in patients with myasthenia gravis. Neurology. 2011 Jun 7;76(23):2017-23. doi: 10.1212/WNL.0b013e31821e5505. Epub 2011 May 11.
Results Reference
background
PubMed Identifier
21061395
Citation
Mandawat A, Kaminski HJ, Cutter G, Katirji B, Alshekhlee A. Comparative analysis of therapeutic options used for myasthenia gravis. Ann Neurol. 2010 Dec;68(6):797-805. doi: 10.1002/ana.22139.
Results Reference
background
PubMed Identifier
22474589
Citation
Bonnan M, Cabre P. Plasma exchange in severe attacks of neuromyelitis optica. Mult Scler Int. 2012;2012:787630. doi: 10.1155/2012/787630. Epub 2012 Feb 12.
Results Reference
background
PubMed Identifier
25664728
Citation
DeSena AD, Noland DK, Matevosyan K, King K, Phillips L, Qureshi SS, Greenberg BM, Graves D. Intravenous methylprednisolone versus therapeutic plasma exchange for treatment of anti-N-methyl-D-aspartate receptor antibody encephalitis: A retrospective review. J Clin Apher. 2015 Aug;30(4):212-6. doi: 10.1002/jca.21363. Epub 2015 Feb 9.
Results Reference
background
PubMed Identifier
2062330
Citation
Rock GA, Shumak KH, Buskard NA, Blanchette VS, Kelton JG, Nair RC, Spasoff RA. Comparison of plasma exchange with plasma infusion in the treatment of thrombotic thrombocytopenic purpura. Canadian Apheresis Study Group. N Engl J Med. 1991 Aug 8;325(6):393-7. doi: 10.1056/NEJM199108083250604.
Results Reference
background
PubMed Identifier
24136342
Citation
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.
Results Reference
background
PubMed Identifier
11867876
Citation
Reeves JH. A review of plasma exchange in sepsis. Blood Purif. 2002;20(3):282-8. doi: 10.1159/000047021.
Results Reference
background
PubMed Identifier
23860248
Citation
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.
Results Reference
background
PubMed Identifier
431695
Citation
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.
Results Reference
background
PubMed Identifier
7432874
Citation
Vain NE, Mazlumian JR, Swarner OW, Cha CC. Role of exchange transfusion in the treatment of severe septicemia. Pediatrics. 1980 Nov;66(5):693-7.
Results Reference
background
PubMed Identifier
6419956
Citation
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.
Results Reference
background
PubMed Identifier
1429495
Citation
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.
Results Reference
background
PubMed Identifier
8052817
Citation
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.
Results Reference
background
PubMed Identifier
12373468
Citation
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.
Results Reference
background
PubMed Identifier
23944206
Citation
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. Erratum In: Crit Care Resusc. 2016 Dec;18(4):289.
Results Reference
background
PubMed Identifier
18828196
Citation
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.
Results Reference
background
PubMed Identifier
10548188
Citation
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.
Results Reference
background
PubMed Identifier
30373638
Citation
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.
Results Reference
background
PubMed Identifier
20568098
Citation
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.
Results Reference
background

Learn more about this trial

Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis

We'll reach out to this number within 24 hrs