CytoSorb Booklet EN 1.0 PDF
CytoSorb Booklet EN 1.0 PDF
CytoSorb Booklet EN 1.0 PDF
CytoSorb Therapy
Indications and set-up
CytoSorb Therapy
REGAIN CONTROL
The Therapy | 01
Indications
Sepsis / Septic shock | 02
Cardiac surgery intraoperative | 03
Cardiac surgery postoperative | 04
Set-up
Short user guide | 05
CytoSorb as stand-alone therapy | 06
CytoSorb combined with renal replacement therapy | 07
CytoSorb in cardiopulmonary bypass | 08
3
The International CytoSorb Registry
02|
02| Sepsis
Sepsis
Septic
Septic
shock
shock
03|
03|Cardiac
Cardiac
surgery
surgery
intraoperative
intraoperative
04|
04|Cardiac
Cardiac
surgery
surgery
postoperative
postoperative
The Therapy
01| The Therapy
The Therapy
8
The Therapy
9
The Therapy
Whole blood
Blutfluss
Section through adsorber Adsorber bead Internal structure
10
02|
Septic shock
Sepsis
Sepsis /
Septic shock
Sepsis / septischer Schock
Grundvoraussetzungen
Basic prerequisites
• Onset of or ongoing acute systemic hyperinflammation
• Standard therapy according to sepsis guidelines established
(e.g. 6 hr sepsis bundle, focus control)
• APACHE II > 25, platelets > 20.000/μl, no DNR order
• CytoSorb is to be employed as adjunctive, not as causative therapy
14
Sepsis / Septic shock
References
1. Peng ZY et al, Kidney Int. 2012 Feb;81(4):363-9 3. Hetz H et al, Int J Artif Organs. 2014 May;37(5):422-6
2. Peng ZY et al, Crit Care Med. 2008 May;36(5):1573-7 4. Sathe P et al, Critical Care 2015, 19(Suppl 1): P130
15
Sepsis / Septic shock
16
Sepsis / Septic shock
17
Sepsis / Septic shock
18
03| Cardiac surgery
intraoperative
Cardiac surgery
intraoperative
Cardiac surgery: Intraoperative use
Basic prerequisites
• Installation never into the mainstream of a
cardiopulmonary bypass (CPB)
• Typical blood flow rate 150 – 500 ml/min
• Anticoagulation with heparin, ACT of 160 - 210 sec
is sufficient for CytoSorb
22
04| Cardiac surgery
postoperative
Cardiac surgery
postoperative
Cardiac
Cardiac
surgery:
surgery:
Postoperative
Postoperative
useuse
Basic
Basic
prerequisites
prerequisites
is based on potentially be avoided. Stabilization
• Onset
d purification • Onset
of or ongoing
of or aongoing
following acute acute
systemic
hyperinflammatorysystemic
hyperinflammation
hyperinflammation
phase
• Standard
• Standard
therapytherapy
established
established
and optimized
and optimized
es excessive could be improved.
• Platelets
• Platelets
> 20.000/μl,
> 20.000/μl,
no DNR no order
DNR order
y mediators.
• In case
• In of
case
sepsis,
of sepsis,
CytoSorbCytoSorb
is to be
is to
employed
be employedas adjunctive,
as adjunctive,
not asnot as
causative
causative
therapytherapy
to reduce the
inflammatory • Treatment
• Treatment duration
duration and indication
and indication for exchange
for exchange of adsorber
of adsorber depend depend
on theon the
clinical
physiologic clinical
course,course,
maximummaximumtreatment
treatment
time per
timeadsorber
per adsorber
24 hours
24 hours
• Continuous
maintained. • Continuous
treatment
treatment
is recommended
is recommended over intermittent
over intermittent
one one
• Typical
• Typical
bloodblood
flow rate
flow150rate– 150
500 –ml/min
500 ml/min
ammatory• Anticoagulation
in-• Anticoagulationwith heparin
with heparin
or citrate,
or citrate,
aPTT aPTT
of 60 of
– 80
60sec
– 80issec
sufficient
is sufficient
for for
CytoSorb
CytoSorb
ous conditions
• With • stand-alone
With stand-alonemodemodeheparin heparin
anticoagulation
anticoagulation
only only
oSorb therapy.
• Contraindications
• Contraindicationsfor extracorporeal
for extracorporeal
bloodblood
circuits
circuits
apply apply
mplications of
Early Early
start of therapy:
start of therapy:
storm Rather
couldRather
avoidavoid
than treat
than organ failure.
treat organ failure.
siehe siehe
Aufbauschema
Aufbauschema
Seite Seite
xx xx
24
Seeset-up
24 page 32
See set-up ff. 32 ff.
page
Cardiac surgery: Postoperative use
25
Cardiac surgery: Postoperative use
References
1. Peng ZY et al, Kidney Int. 2012 Feb;81(4):363-9 3. Hetz H et al, Int J Artif Organs. 2014 May;37(5):422-6
2. Peng ZY et al, Crit Care Med. 2008 May;36(5):1573-7 4. Sathe P et al, Critical Care 2015, 19(Suppl 1): P130
26
Cardiac
Cardiac surgery:
surgery: Postoperative
Postoperative use
use
Signs
Signs of
of a
a successful
successful CytoSorb
•• Stabilization
CytoSorb Therapy
Therapy
Stabilization of of hemodynamic
hemodynamic situation
situation
-- Decreasing
Decreasing vasopressor need
vasopressor need
-- Less
Less positive
positive or
or stabilization
stabilization of
of fluid
fluid balance
balance
-- No
No further
further increase
increase of
of lactate
lactate level
level
•• Decrease
Decrease ofof IL-6
IL-6 level
level (if
(if measured)
measured) and
and of
of WBC,
WBC, PCT
PCT (in
(in case
case of
of sepsis),
sepsis),
CRP
CRP
-- When
When assessing
assessing thethe course
course of
of PCT,
PCT, be
be aware
aware of
of direct,
direct, partial
partial PCT
PCT
removal
removal by
by CytoSorb
CytoSorb
•• Stabilization
Stabilization of of other
other organ
organ functions,
functions, e.g.
e.g.
-- NoNo further
further deterioration
deterioration of
of liver
liver function
function parameters
parameters
-- No
No further
further increase
increase of
of ventilatory
ventilatory support
support necessary
necessary
-- Improvement
Improvement of of coagulation
coagulation situation
situation
27
27
Cardiac surgery: Postoperative use
28
05|
05| Short
Shortuser
user
guide
guide
06|
06| CytoSorb
CytoSorbasas
stand-alone
stand-alone
therapy
therapy
07|
07| CytoSorb
CytoSorb
renal
renal
combined
combined
replacement
replacement
with
with
therapy
therapy
08|
08| CytoSorb
CytoSorbin in
cardiopulmonary
cardiopulmonary
bypass
bypass
Short user guide
05|
Set-up:
Short user guide
Short user guide
32
Short
Shortuser
userguide
guide
Anticoagulation
Anticoagulation
• • Anticoagulation
Anticoagulationmust mustbebeeffective
effectiveatattreatment
treatmentstart
start
• • InInintensive
intensivecare
carepatients
patientsananaPTT
aPTTofof6060toto8080sec.,
sec.,when
whenusing
usingduring
during
heart
heartsurgery
surgeryananACT
ACTofof160
160toto210
210seconds,
seconds,isissufficient
sufficientfor
forCytoSorb.
CytoSorb.
Specifications
Specificationsofofthethedevice
devicemanufacturer
manufacturerhave havetotobe
beobserved
observed
• • The
TheaPTT
aPTTand
andACTACTshould
shouldbebechecked
checkedregularly
regularlyduring
duringtherapy
therapytotoensure
ensure
adequate
adequateanticoagulation
anticoagulation
General
Generalmaterials
materialsrequired:
required:
• • CytoSorb
CytoSorbadsorber
adsorber
• • Mounting
Mountingholder
holderfor
forCytoSorb
CytoSorb
• • 6 6scissor
scissorclamps
clamps
• • Isotonic
Isotonicsaline
salinesolution
solutionwith
withLuer
LuerLock
Lockfor
forflushing
flushing
(2l(2lNaCl
NaCl0.9%,
0.9%,sterile)
sterile)
3333
Your notes
34
06|
stand-alone
Set-up:
therapy
CytoSorb as
stand-alone therapy
CytoSorb as stand-alone therapy
Set-up
1. Set-up the device according to the manufacturer's instructions (dry)
2. Mount CytoSorb vertically into holder
3. Start blood pump and deaerate arterial tubing system
4. Stop blood pump and clamp arterial tubing system at by using scissors
clamp
5. Only remove the port plug on the CytoSorb inlet (bottom)
6. Connect CytoSorb bubble-free with arterial tubing system (observe flow
direction)
7. Now remove the blood outlet port plug (top) and connect CytoSorb
with venous tubing system
8. Remove scissor clamp from arterial tubing system
9. Start blood pump (approx. 200 ml/min) and rinse system with 2 liters of
saline solution
10. Remove CytoSorb from the holder and deaerate it by tapping
11. Start patient treatment according to manufacturer's instructions
36
Set-up
blood pump
bubble
catcher
venous
tubing system
arterial
blood to patient
tubing system
blood from pump
37
Your notes
38
07|
Set-up:
CytoSorb combined with
renal replacement therapy
renal replacement
CytoSorb combined with renal replacement therapy
Set-up 1 of 2
1. Completely prepare the device according to manufacturer's instructions
(incl. flushing). If necessary during ongoing renal replacement therapy first
interrupt the treatment (return blood and disconnect patient according to
the manufacturer's instructions of each device)
2. Connect saline solution with A , deaerate and close red tubing clamp of A
3. Connect bubble-free with CytoSorb blood inlet (bottom)
(observe flow direction)
4. Connect CytoSorb blood outlet (top) with E , B , C and D
5. Open red tube clamp of A and rinse CytoSorb by gravity with 2 liters of
saline and deaerate it by tapping
6. Close red tube clamp of A and blue tube clamp of C
40
Set-up before dialyzer
Additional materials:
Priming adapter 1
saline
solution 2l A Red Luer Lock – red DIN Lock
Color neutral DIN Lock – color
B neutral DIN Lock
C Blue DIN Lock – blue Luer Lock
E D 2l empty bag
Adapter 1
E Color neutral DIN Lock –
A color neutral DIN Lock
41
CytoSorb combined with renal replacement therapy
Set-up 2 of 2
7. Stop blood pump
8. Clamp all tubes at the dialyzer at by use of scissor clamps
9. Disconnect A from CytoSorb blood inlet (bottom) and discard it
10. Disconnect arterial blood tube from dialyzer blood inlet and connect
bubble-free with CytoSorb blood inlet (bottom)
11. Disconnect B from E and discard B , C and D
12. Connect E bubble-free with dialyzer blood inlet
13. Remove all scissor clamps at
14. Start patient treatment according to manufacturer‘s instructions
42
Set-up before dialyzer
blood pump E
dialyzer
bubble
catcher
arterial
tubing system
blood from pump
venous tubing
system
blood to patient
possible configuration
43
CytoSorb combined with renal replacement therapy
Set-up 1 of 2
1. Completely prepare the device according to manufacturer‘s instructions
(incl. flushing). If necessary during ongoing renal replacement therapy first
interrupt the treatment (return blood and disconnect patient according to
the manufacturer‘s instructions of each device)
2. Connect saline solution with A and B , deaerate and close red tubing
clamp of A
3. Connect B bubble-free with CytoSorb blood inlet (bottom) (observe flow
direction)
4. Connect CytoSorb blood outlet (top) with C , D and E
5. Open red tube clamp of A and rinse CytoSorb by gravity with 2 liters of
saline and deaerate it by tapping
6. Close red tube clamp of A and blue tube clamp of B . Clamp B
before and C after CytoSorb at by using scissor clamps
44
Set-up after dialyzer
Additional materials:
saline
solution 2l D Priming adapter 2
A Red Luer Lock – red Luer Lock
B
D Blue Luer Lock – blue Luer Lock
E 2l empty bag
Adapter 2
C Color neutral Luer Lock –
B color neutral DIN Lock
A
Color neutral DIN Lock –
C blue Luer Lock
45
CytoSorb combined with renal replacement therapy
Set-up 2 of 2
7. Stop blood pump
8. Clamp blood tubes at the dialyzer blood outlet F and before the venous
bubble catcher G at by use of scissor clamps
9. Disconnect saline solution and A from B and discard it
10. Connect B with blood tube from dialyzer blood outlet F
11. Connect C from CytoSorb blood outlet (top) with line to venous bubble
catcher G
12. Remove all scissor clamps at
13. Start patient treatment according to manufacturer‘s instructions
46
Set-up after dialyzer
F B C G
blood pump
venous
bubble
dialyzer catcher
arterial
tubing system
blood from pump
venous
tubing system
possible configuration blood to patient
47
CytoSorb exchange
48
CytoSorb exchange
B
D
used
C fresh
A
50
08|
Set-up:
CytoSorb in
cardiopulmonary bypass
cardiopulmonary
bypass
CytoSorb in cardiopulmonary bypass
Set-up 1 of 2
1. Completely prepare the device according to manufacturer's instructions
(incl. flushing)
2. Connect saline solution with A , deaerate and clamp with roller clamp B
3. Connect bubble-free with CytoSorb blood inlet (bottom)
(observe flow direction)
4. Connect CytoSorb blood outlet (top) with C and D
5. Open roller clamp B and and rinse CytoSorb by gravity with 2 liters
of saline solution and deaerate it by tapping
6. Close clamps at B and D
52
CytoSorb in cardiopulmonary bypass
Additional materials:
Adapter 3
saline
solution 2l A Color neutral Luer Lock – Color neu-
tral DIN Lock with roller clamp B
C Color neutral DIN Lock – Color
neutral Luer Lock
D 2l empty bag
E High-flow three-way valve
C
A
53
CytoSorb in cardiopulmonary bypass
Set-up 2 of 2
7. Vertically install CytoSorb at the heart-lung-machine by using the holder
8. 2. Disconnect A from the saline bag and connect it bubble-free to a Luer Lock
F on the blood line after the pump by use of a three-way high flow valve E .
9. Connect C via a Luer Lock connection to the reservoir G
10. If necessary, regulate the flow via roller clamp B
NOTES
• For safety reasons, the installation of CytoSorb in cardiopulmonary bypass
is always carried out via a Luer lock branch between the pump and oxygenator,
forming a reflux to the reservoir
• Due to the diameter of the Luer lock connection the blood flow through
CytoSorb is limited to 400 to 500 ml/min
• In order to avoid clotting, a continuous blood flow has to be ensured after
start of the CytoSorb therapy
54
CytoSorb in cardiopulmonary bypass
reservoir* G C
blood pump
blood line
E
oxygenator*
A
* exemplary presentations B 55
Your notescombined with renal replacement therapy
CytoSorb
Set-up 2 of 2
7. Stop blood pump
8. Clamp blood tubes at the dialyzer blood outlet F and before the venous
bubble catcher G at by use of scissor clamps
9. Disconnect saline solution and A from B and discard it
10. Connect B with blood tube from dialyzer blood outlet F
11. Connect C from CytoSorb blood outlet (top) with line to venous bubble
catcher G
12. Remove all scissor clamps at
13. Start patient treatment according to manufacturer‘s instructions
46
50
®
REGAIN CONTROL
CytoSorb and CytoSorbents are trade marks of the CytoSorbents Corporation, USA. B1031R01EN2016 © Copyright 2015, CytoSorbents Europe GmbH. All rights reserved.