1)cytosorb register planung 2)studie seraph microbind: exthera …€¦ · interessenskonflikt...

Interessenskonflikt

1) Cytosorb Register Planung

2) Studie Seraph Microbind: ExThera Medical

3) Fan von Arbeitsgruppe PD Dr. David, MHH

Cytokinelimination bei Sepsis

JanT Kielstein | Braunschweig

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

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

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.

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

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

JAMA 315(8):801-810, 2016

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

JAMA 315(8):801-810, 2016

Liste der FDA /EMA zugelassenen Medikamente zur Therapie der Sepsis

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

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

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

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

JAMA 315(8):801-810. 2016

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

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

……stay tuned

Cytokinelimination bei Sepsis

1) Sepsis – unmet medical need

2) Cytokine in der Sepsis

3) Adsorber

4) Alternative Technologien

Plasma exchange

SCHWARTZ et al. Journal of Clinical Apheresis

31:149–162, 2016

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

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

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

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

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

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

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

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

markers SCHMIDT et al.

BMC Obesity 2:37, 2015

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

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

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

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

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

Patients on Hemodialysis

I will survive