Transcript Citra Lock presentation

DURALOCK C
Catheter
Lock
Solution
medCOMP
Duralock C
• protects against catheter related infection
medCOMP
Duralock C
• protects against catheter related infection
• prevents the formation of biofilm
medCOMP
Duralock C
• protects against catheter related infection
• prevents the formation of biofilm
• prevents catheter clotting  use of thrombolytic agents
medCOMP
Duralock C
• protects against catheter related infection
Literature shows catheter related bacteremia incidence of
3,0 – 7,0 episodes/1.000 cath.days
medCOMP
Duralock C
• protects against catheter related infection
Literature shows catheter related bacteremia incidence of
3,0 – 7,0 episodes/1.000 cath.days
Tunneled
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Non tunneled
Duralock C
• protects against catheter related infection
Most cultured microbes:
• S. aureus
• Coagulase negative s. aureus
• S epidermidis
• Candida albicans
• E. Agglomerans
• P. aeruginosa
• Enterococcus faecalis
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Duralock C
• protects against catheter related infection
Consequenses of CRB:
• Serious complications in the use of catheters
medCOMP
Duralock C
• protects against catheter related infection
Consequenses of CRB:
• Serious complications in the use of catheters
• High cost treatment:
- catheter exchange
- hospitalization (for example for IV treatment with
antibiotics
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Duralock C
• protects against catheter related infection
Consequenses of CRB:
• Serious complications in the use of catheters
• High cost treatment:
- catheter exchange
- hospitalization (for example for IV treatment with
antibiotics
• Interruption of treatment
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Duralock C
• protects against catheter related infection
Consequenses of CRB:
• Serious complications in the use of catheters
• High cost treatment:
- catheter exchange
- hospitalization (for example for IV treatment with
antibiotics
• Interruption of treatment
• Increasing problem of antibiotic resistance
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Power of Duralock C
• protects against catheter related infection
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Power of Duralock C
• protects against catheter related infection
Concentrated Sodium Citrate (23%) for Catheter Lock
Stephen R. Ash et al, Hemodialysis International 4:22-31, 2000
Protocol:
• 40 patients followed for several catheter locking solutions:
1/98-8/98: heparin 5000 units or 10 000 units
 9/98-11/98: 10% sodium citrate (pH 6.5) with 3 mg/mL gentamicin
 12/98-3/99: 20% sodium citrate with 3 mg/mL gentamicin
 4/99-6/99: 46,7% sodium citrate
 7/99-10/99: heparin 5000 or 10 000 units
 11/99-3/00: 23% sodium citrate
Study endpoints:
• The incidence of symptomatic bactaeremia (calculated as the number of episodes per 3000
patient-days)
• Use of urokinase
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Power of Duralock C
• protects against catheter related infection
Infection Rate
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Power of Duralock C
• protects against catheter related infection
Trisodium citrate 30%
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Heparin 5000 IU/ml
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de
Vondervoort and P.M. ter Wee
Nephrol Dial Transplant (2002) 17: 2189–2195
Power of Duralock C
40
mm
S. aureus
Disk Diffusion Susceptibility Test
• protects against catheter related infection
35
E. coli
30
S. epidermidis
P. aeruginosa
25
C. albicans
20
15
10
5
0
Heparine
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Trisodiumcitrate
2.2%
Trisodiumcitrate
7.5%
Trisodiumcitrate
15%
Trisodiumcitrate
30%
Trisodiumcitrate
7.5%/ gentamicin
1mg/ml
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervo
and P.M. ter Wee
Nephrol Dial Transplant (2002) 17: 2189–2195
Power of Duralock C
• protects against catheter related infection
Heparin 5000 IU/ml
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M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de
Vondervoort and P.M. ter Wee
Nephrol Dial Transplant (2002) 17: 2189–2195
Study design
Primary endpoint:
Catheter survival
Interimanalysis
Secondary endpoints
- infection
- bacteremia
bacteremia
(200 catheters)
- exit site infection
- thrombosis
- flow problems
- use of urokinase
- side effects
- bleeding
- thrombocytopenia
- systemic reactions after locking
291 hemodialysis catheters
Catheters
tunneled cuffed
jugular
subclavian
femoral
untunneled
jugular
subclavian
femoral
citrate 30%
heparin
total
148
143
291
50
49
1
0
98
77
1
20
48
48
0
0
95
69
2
24
98
97
1
0
193
146
3
48
Catheter days
8431
8116
16547
Days per catheter
57.0
56.8
56.9
tunneled cuffed
untunneled
97.1
36.5
94.2
37.8
95.7
37.1
Power of Duralock C
Why protects a citrate solution
against catheter related infections?
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Power of Duralock C
Why protects a citrate solution
against catheter related infections?
Citrate = Na3C6H5O7
combined with
citric acid = C3H5O(COO)33−
binds
double positive ionized molecules: Ca++ / Mg++
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Power of Duralock C
Apart from Mg++ binding, removal of Ca++ from
the surrounding milieu can be an explanation for the
antimicrobial properties of TSC. Ca++ may regulate
several genes responsible for growth and survival of
microbes. Holland et al. [19] demonstrated that cell
division in E.coli in particular appears to be very
sensitive to the level of cellular Ca++.
Weijmer MC, Debets-Ossenkopp YJ, Van de Vondervoort
FJ, ter Wee PM: Superior antimicrobial activity of trisodium
citrate over heparin for catheter locking. Nephrol Dial
Transplant 17: 2189–2195, 2002
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Power of Duralock C
• protects against catheter related infection
“We conclude that in our in vitro study using standardized antimicrobial
susceptibility tests we demonstrated that TSC 30% was the most potent
antimicrobial locking solution and that its hyperosmolality was of minor
importance to explain the inhibitory effects of TSC on microbial growth.”
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M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de
Vondervoort and P.M. ter Wee
Nephrol Dial Transplant (2002) 17: 2189–2195
Power of Duralock C
• protects against catheter related infection
Randomized, Clinical Trial Comparison of Trisodium
Citrate 30% and Heparin as Catheter-Locking Solution in
Hemodialysis Patients
Marcel C. Weijmer, Marinus A. van den Dorpel, Peter J.G. Van de Ven, Pieter M. ter Wee, Jos A.C.A. van Geelen,
Johannes O. Groeneveld, Brigitte C. van Jaarsveld, Marjon G. Koopmans, Caatje Y. le Poole, Anita M. Schrander-Van
der Meer, Carl E.H. Siegert, Koen J.F. Stas; for the CITRATE Study Group
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Catheter survival
50
45
40
46
18%
35
TSC
30
25
28
20
P=0.014
15
heparin
10
5
0
% catheters
preliminary removed
heparin
days in place
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citrate 30%
Bacteremia free survival
TSC
35
30
P=0.0002
25
33
73%
20
heparin
15
10
5
9
0
total episodes
bacteremia
days in place
heparin
citrate 30%
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Infection related admissions
P=0.002
30
P=0.001
250
225
25
200
245
175
20
150
21
125
15
heparine
citraat 30%
100
10
75
50
5
6
25
44
0
0
admissions due
to infections
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hospital days due to
infections
Mortality
P=0.35
P=0.022
20
18
16
18
14
12
10
13
heparin
8
citrate 30%
6
4
5
0
2
0
overall
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Bacteremia related
Duralock C
• Prevents formation of biofilm
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Duralock C
• Prevents formation of biofilm
Micro organisms
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Duralock C
• Prevents formation of biofilm
Biofilm grows under the influence of poly sacharides, produced by micro organisms.
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Duralock C
• Prevents formation of biofilm
Biofilm grows under the influence of poly sacharides, produced by micro organisms.
Heparin is a poly sacharide combined with an anti thrombin
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Duralock C
• Prevents formation of biofilm
Biofilm grows under the influence of poly sacharides, produced by micro organisms.
Heparin is a poly sacharide combined with an anti thrombin
Heparin induces the growth of biofilm
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Duralock C
Crit Care Med. 1992 May;20(5):665-73.
Biofilms on indwelling vascular catheters,
Passerini. L, Lam K, Costerton JW, King EG
Method:
…examined 42 arterial and 26 central venous catheters that had
been in place in ICU patients between 1 and 14 days for the
presence of bacterial biofilms by scanning electron
microscopy, transmission electron microscopy, and a special
scraping/sonication bacterial recovery technique.
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Duralock C
• Prevents formation of biofilm
Crit Care Med. 1992 May;20(5):665-73.
Biofilms on indwelling vascular catheters,
Passerini. L, Lam K, Costerton JW, King EG
Conclusion:
1. Extensive biofilm formation on all 42 arterial and 26 central
venous catheters.
2. Bacteria within the biofilms on 69% (29/42) of the arterial and
88% (23/26) of the central venous catheters.
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Power of Duralock C
• Prevents formation of biofilm
Catheter lock solutions influence staphylococcal biofilm formation on
abiotic surfaces
Robert M. Q. Shanks1, Jennifer L. Sargent1, Raquel M. Martinez1, Martha L. Graber2 and George
A. O’Toole1
1Department of Microbiology and Immunology, Dartmouth Medical School, Hanover, NH 03755 and
2Department of Medicine, Section of Hypertension and Nephrology, Dartmouth Hitchcock Medical
Center, Lebanon, NH 03766, USA
Nephrol Dial Transplant (2006) 1 of 9
doi:10.1093/ndt/gfl170
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Power of Duralock C
• Prevents formation of biofilm
Catheter lock solutions influence staphylococcal biofilm formation on
abiotic surfaces
This in vitro study demonstrates that heparin alternatives, sodium citrate and sodium
EDTA, can prevent the formation of S. aureus biofilms, suggesting that they may reduce
the risk of biofilm-associated complications in indwelling catheters.
Nephrol Dial Transplant (2006) 1 of 9
doi:10.1093/ndt/gfl170
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Duralock C
• prevents catheter clotting  use of thrombolytic agents
Catheter related thrombosis is often the cause of low catheter blood flows.
medCOMP
Duralock C
• prevents catheter clotting  use of thrombolytic agents
Catheter related thrombosis is often the cause of low catheter blood flows.
Low blood flow  inefficient treatment  low Kt/V
medCOMP
Duralock C
• prevents catheter clotting  use of thrombolytic agents
Catheter related thrombosis is often the cause of low catheter blood flows.
Low blood flow  inefficient treatment  low Kt/V
Treatment: Expensive thrombolitic agents (TpA, Urokinase, Streptokinase)
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Power of Duralock C
• prevents catheter clotting  use of thrombolytic agents
Under influence of
Ca++
So...
medCOMP
Power of Duralock C
• prevents catheter clotting  use of thrombolytic agents
Under influence of
Ca++
So...
Binding Ca++ in
the catheter environment,
stops the proces of clotting
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Flow problems
heparin
P=0.754
TSC
30
25
20
15
20
18
10
getunneld = ongetunneld
5
0
% removed for
flow problem
days in place
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heparin
citrate 30%
Power of Duralock C
• prevents catheter clotting  use of thrombolytic agents
medCOMP
Ash SR, et al. ASN 1999 A1375
Leakage lock solution
Duralock C
Bleeding complications
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Bayes B et al, Nephrol Dial Transpl 1999; 14; 2532
Power of Duralock C
• protects against catheter related infection
Sodium citrate for filling haemodialysis catheters
“We recommend filling the catheter with sodium citrate 46,7%
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Bayes B et al, Nephrol Dial Transpl 1999; 14; 2532
Duralock C
Bleeding complications
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Risk of heparin lock-related bleeding when using indwelling
venous catheters in haemodialysis, Hüseyin Karaaslan et al,
Service de Néphrologie CHU Dupuytren, Limoges, France
Nephrol Dial Transpant, (2001) 16: 2072-2074
Consequences of leakage lock solution
Bleeding complications during citrate-trial
P=0.005
P=0.01
20
18
16
heparin
19
citrate 30%
16
14
12
10
8
6
4
6
5
2
0
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After insertion
During follow up
DURALOCK C
“The injected concentration Citra-Locktm decreases 30% in the inter dialytic periode
in jugular and subclavian catheters. Femoral catheters show a decrease of 90%.
Cornelius J. Doorenbos, Marjo Van den Elsen-Hutten, Margret J. M. Heuven and Jan
Hessels, Estimation of trisodium citrate (Citra-LockTM) remaining in central
venous catheters after the interdialytic interval, Nephrology Dialysis Transplantation
2006 21(2):543-545
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DURALOCK C
“The injected concentration Citra-Locktm decreases 30% in the inter dialytic period
in jugular and subclavian catheters. Femoral catheters show a decrease of 90%.
46,7%
30%
medCOMP
Anti microbial protection, Weijmer)
30%
Duralock C
Literature reviews:
1. Beathard GA: Management of bacteremia associated with tunneled-cuffed hemodialysis catheters. J Am Soc Nephrol 10: 1045–1049,
1999
2. Weijmer MC, ter Wee PM: Temporary vascular access for hemodialysis treatment. Current guidelines and future directions. Contrib
Nephrol 137: 38–45, 2002
3. Costerton JW, Stewart PS, Greenberg EP: Bacterial biofilms: A common cause of persistent infections. Science 284:1318–1322, 1999
4. Raad I: Intravascular-catheter-related infections. Lancet 351: 893–898, 1998
5. Bayes B, Bonal J, Romero R: Sodium citrate for filling haemodialysis catheters. Nephrol Dial Transplant 14: 2532–2533, 1999
6. Karaaslan H, Peyronnet P, Benevent D, Lagarde C, Rince M, Leroux-Robert C: Risk of heparin lock-related bleeding when using
indwelling venous catheter in haemodialysis. Nephrol Dial Transplant 16: 2072–2074, 2001
7. Dogra GK, Herson H, Hutchison B, Irish AB, Heath CH, Golledge C, Luxton G, Moody H: Prevention of tunneled
hemodialysis catheter-related infections using catheter-restricted filling with gentamicin and citrate: A randomized
controlled study. J Am Soc Nephrol 13: 2133–2139, 2002
8. Weijmer MC, Debets-Ossenkopp YJ, Van de Vondervoort FJ, ter Wee PM: Superior antimicrobial activity of trisodium citrate over
heparin for catheter locking. Nephrol Dial Transplant 17: 2189–2195, 2002
9. Ash SR, Mankus RA, Sutton JM, Criswell ER, Crull CC, Velasquez KA, Smeltzer BD, Ing TS: Concentrated sodium citrate (23%) for
catheter lock. Hemodial Int 4: 22–31, 2000
10. Stas KJ, Vanwalleghem J, Moor BD, Keuleers H: Trisodium citrate 30% vs heparin 5% as catheter lock in the interdialytic period in
twin- or double-lumen dialysis catheters for intermittent haemodialysis. Nephrol Dial Transplant 16:1521–1522, 2001
11. Twardowski ZJ: High-dose intradialytic urokinase to restore the patency of permanent central vein hemodialysis
catheters. Am J Kidney Dis 31: 841–847, 1998
12. Buturovic J, Ponikvar R, Kandus A, Boh M, Klinkmann J, Ivanovich P: Filling hemodialysis catheters in the interdialytic period: Heparin
versus citrate versus polygeline: Aprospective randomized study. Artif Organs 22: 945–947,1998
13. Betjes MG, Van Agteren M: Prevention of dialysis catheterrelatedsepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial
Transplant 19: 1546–1551, 2004
14. De Wachter DS, Weijmer MC, Kausylas M, Verdonck PR: Do catheter side holes provide better blood flows? Hemodial Int 6: 40–46,
2002
15. Twardowski ZJ: The clotted central vein catheter for haemodialysis. Nephrol Dial Transplant 13: 2203–2206, 1998
16. FDA Issues Warning on triCitrasol® Dialysis Catheter Anticoagulant.FDA Talk Paper T00-16, Rockville, MD, US Food and Drug
Administration, 2000
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Duralock C
Heparin
–
–
–
–
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Anticoagulant
Systemic effect
Generates bleeding risks
Promotes bacterial growth, poly sacharide is feed for
micro organisms
Duralock C
Heparin
–
–
–
–
Anticoagulant
Systemic effect
Generates bleeding risks
Promotes bacterial growth, poly sacharide is feed for
micro organisms
– Promotes formation of biofilm
medCOMP
Power of Duralock C
Conclusions:
1. Trisodium citrate, in a concentration of at least 30% shows an antimicrobial effect
(Weijmer et al)
2. Trisodium citrate 30% shows a decrease of CRB of 75% in a randomized
controlled multi centre trial (Weijmer et al).
3. Trisodium citrate 30% doesn’t effect positively on blood flow and use of
thrombolytic agents (Weijmer et al)
4. Trisodium citrate 46,7% does show in In vivo studies a decrease in CRB and use
of thrombolytic agents like Urokinase.
5. There is leakage of catheter lock solutions in the inter dialytic period, resulting in
hight ATTP results, constantly measurable gentamycin levels or decreased
trisodium citrate levels.
6. Catheter lock solutions based on antibiotics promote the risk of anti biotic
resistance.
medCOMP
DURALOCK C
•
•
•
•
•
•
No formation of biofilm
Anti microbial effect without anti biotics
No drug-resistant bacterial strains
No bleeding complications
Proven anticoagulant
Bio-compatible without systemic effects
medCOMP
‫‪Action plan- february‬‬
‫‪22.26.2‬‬
‫‪15-19.2‬‬
‫‪8-12.2‬‬
‫‪1-5.2‬‬
‫ליווי אבלואציות‬
‫במחלקות הנפרולוגיה‬
‫הצגת הדורה לוק‬
‫בישיבות הצוות של‬
‫המחלקות‬
‫פגישות עם מנהלי מחלקות‬
‫הנפרולוגיה‬
‫פגישות עם מנהלי‬
‫מחלקות הנפרולוגיה‬
‫התחלת אבלואציות‬
‫במחלקות הנפרולוגיה‬
‫הצגת הדורה לוק בישיבות‬
‫הצוות של המחלקות‬
‫המשך צפייה‬
‫בפרוצדורות המחלקות‬
‫האנגיו‪ -‬שעות ‪14:00-‬‬
‫‪17:00‬‬
‫המשך צפייה בפרוצדורות‬
‫המחלקות האנגיו‪ -‬שעות‬
‫‪14:00-17:00‬‬
‫המשך צפייה‬
‫בפרוצדורות‬
‫המחלקות האנגיו‪-‬‬
‫שעות ‪14:00-17:00‬‬
‫‪Action plan- january‬‬
‫‪25-29.1‬‬
‫‪18-22.1‬‬
‫מצגת קטטרים לטווח קצר‪26.1.09 -‬‬
‫מצגת דורה לוק‪22.1.09 -‬‬
‫הצגת דף הסבר דורה לוק‪26.1.09 -‬‬
‫המשך צפייה בפרוצדורות המחלקות‬
‫האנגיו‪ -‬שעות ‪8:00-12:00‬‬
‫תיאום פגישות עם הרופאים הרלוונטים‪29.1 -‬‬
‫המשך צפייה בפרוצדורות המחלקות האנגיו‪-‬‬
‫שעות ‪8:00-12:00‬‬
‫‪Action plan- march‬‬
‫‪22.26.3‬‬
‫‪15-19.3‬‬
‫‪8-12.3‬‬
‫‪1-5.3‬‬
‫הוצאת דרישות‬
‫למוצר מול מחלקות‬
‫הרכש‬
‫ליווי אבלואציות‬
‫במחלקות הנפרולוגיה‬
‫ליווי אבלואציות במחלקות‬
‫הנפרולוגיה‬
‫ליווי אבלואציות‬
‫במחלקות‬
‫הנפרולוגיה‬
‫מעקב אחר הזמנות‬
‫למוצר מול מחלקות‬
‫הרכש‬
‫הנפקת הצעות מחיר‬
‫למנהלי מחלקות‬
‫הנפרולוגיה‬
‫הנפקת הצעות מחיר‬
‫למנהלי מחלקות‬
‫הנפרולוגיה‬
‫הוצאת דרישות למוצר‬
‫מול מחלקות הרכש‬
‫השתלבות במחלקות‬
‫האנגיו הרלוונטיות‬
‫וחפיפה על הלקוח‪+‬‬
‫היכרויות עם מנהלי‬
‫היחידות‪.‬‬
‫השתלבות במחלקות‬
‫האנגיו הרלוונטיות‬
‫וחפיפה על הלקוח‪+‬‬
‫היכרויות עם מנהלי‬
‫היחידות‪.‬‬
‫השתלבות במחלקות‬
‫האנגיו הרלוונטיות‬
‫וחפיפה על הלקוח‪+‬‬
‫היכרויות עם מנהלי‬
‫היחידות‪.‬‬
DURALOCK C
Q&A
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