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Interessenskonflikt 1) Cytosorb Register Planung 2) Studie Seraph Microbind: ExThera Medical 3) Fan von Arbeitsgruppe PD Dr. David, MHH

1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

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Page 1: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Interessenskonflikt

1) Cytosorb Register Planung

2) Studie Seraph Microbind: ExThera Medical

3) Fan von Arbeitsgruppe PD Dr. David, MHH

Page 2: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Cytokinelimination bei Sepsis

JanT Kielstein | Braunschweig

Page 3: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

Page 4: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

Page 5: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of

survival in human septic shock KUMAR et al. Crit Care Med. 34(6):1589-96, 2006

Page 6: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

From: The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

JAMA 315(8):801-810, 2016

SEPSIS: life threatening organ dysfunction caused ba a dysregulated host respone to infection.

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organ dysfunction: acute change in total SOFA Score >2 points consequent to infection.

From: The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

JAMA 315(8):801-810, 2016

Page 8: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

From: The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

JAMA 315(8):801-810, 2016

Page 9: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

From: The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

JAMA 315(8):801-810, 2016

Page 10: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Liste der FDA /EMA zugelassenen Medikamente zur Therapie der Sepsis

Page 11: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

Page 12: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Extracorporeal therapies in non-renal disease: treatment of sepsis and the peak concentration hypothesis

RONCO et al. Blood Purif 22(1):164-74, 2004

Excess pro- and anti-inflammatory

mediators removed by continuous combined therapies

Unselective high efficiency extracorporeal therapies might remove excess of pro- and anti-inflammatory mediators diminishing the amplified inflammatory response and the immunoparalisis induced by cell hyporesponsiveness

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The prognostic value of concomitant assessment of NT-proCNP, C-reactive protein, procalcitonin and

inflammatory cytokines in septic patients. TOMASIUK et al. Crit Care 18(3): 440, 2014

Page 14: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

Page 15: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter

randomized control trial (n=243) PAYEN et al. Intensive Care Med 41(6):975-84, 2015

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Efficacy of polymyxin B-immobilized fiber hemoperfusion for patients with septic shock caused by

Gram-negative bacillus infection SAITO et al. PLoS One 12(3):e0173633, 2017

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biocompatible, highly porous polymer bead designed to capture and adsorb cytokines (~10-50 kDa)

Page 18: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Effect of extracorporeal cytokine removal on vascular barrier function in a septic shock patient

DAVID et al. J Intensive Care 5:12, 2017

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Effect of extracorporeal cytokine removal on vascular barrier function in a septic shock patient

DAVID et al. J Intensive Care 5:12, 2017

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Hemoadsorption by CytoSorb in septic patients: a case series (n=26)

KOGELMANN et al. Critical Care 21(1):74, 2017

Page 21: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Hemoadsorption by CytoSorb in septic patients: a case series (n=26)

KOGELMANN et al. Critical Care 21(1):74, 2017

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Efficacy and cardiovascular tolerability of EDD in critically ill patients: a randomized controlled study

KIELSTEIN et al. AJKD 43: 342-349, 2004

UF volume EDD 2.97 0.55 L/12h CVVH 3.28 0.39 L/24 h

Norepinephrine dose at 0 h EDD 0.47 0.11 CVVH 0.47 0.14 μg/kg/min Norepinephrine dose at 12 h EDD 0.45 0.12 CVVH 0.42 0.13 μg/kg/min

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Hemoadsorption by CytoSorb in septic patients: a case series (n=26)

KOGELMANN et al. Critical Care 21(1):74, 2017

Page 24: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

From: The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

JAMA 315(8):801-810. 2016

Page 25: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Effect of hemoadsorption during cardiopulmonary bypass surgery – a blinded, randomized, controlled pilot study using

a novel adsorbent (n=37) BERNARDI et al. Critical Care 20:96, 2016

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Effect of hemoadsorption during cardiopulmonary bypass surgery – a blinded, randomized, controlled pilot study using

a novel adsorbent (n=37) BERNARDI et al. Critical Care 20:96, 2016

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……stay tuned

Page 28: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

Page 29: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

Plasma exchange

SCHWARTZ et al. Journal of Clinical Apheresis

31:149–162, 2016

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Plasma exchange in treatment refractory septic shock : Presentation of a therapeutic add-on strategy DAVID et al. Med Klin Intensivmed Notfmed 112(1):42-46, 2017

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Plasmapheresis in severe sepsis and septic shock: a prospective, randomised, controlled trial

BUSUND et al. Intensive Care 28:1434–1439, 2002

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Plasmapheresis in severe sepsis and septic shock: a prospective, randomised, controlled trial

BUSUND et al. Intensive Care 28:1434–1439, 2002

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Therapeutic Plasma Exchange Decreases Levels of Routinely Used Cardiac and Inflammatory Biomarkers

TUTAREL et al. PLoS ONE 7(6): e38573, 2012

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Effect of TPE on plasma levels and total removal of adipokines and inflammatory

markers SCHMIDT et al.

BMC Obesity 2:37, 2015

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Therapeutic plasma exchange as rescue therapy in severe sepsis and septic shock: retrospective observational

single-centre study of 23 patients HADEM et al. BMC Anesthesiol 7;14(1):24, 2014

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Therapeutic plasma exchange as rescue therapy in severe sepsis and septic shock: retrospective observational

single-centre study of 23 patients HADEM et al. BMC Anesthesiol 7;14(1):24, 2014

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The prognostic value of ADAMTS13 deficiency in septic shock patients involves interleukin-6 and is not dependent

on disseminated intravascular coagulation PEIGNE et al. Crit Care 18;17(6):R273, 2013

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Randomized, prospective, multicenter, open-label, controlled, parallel-group trial investigating the efficacy of add-on plasma-

exchange as an adjunctive strategy against septic shock with multiple organ dysfunction (EXCHANGE trial)

PI: PD Dr. Sascha David Hannover Medical School, GERMANY

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Safety and Performance Evaluation of the Seraph® Microbind® Affinity Blood Filter for Reducing Bacteremia in

Patients on Hemodialysis

Page 41: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe
Page 42: 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera …€¦ · Interessenskonflikt 1)Cytosorb Register Planung 2)Studie Seraph Microbind: ExThera Medical 3)Fan von Arbeitsgruppe

I will survive