1. DURALOCK C
Catheter
Lock
Solution
medCOMP

2. Duralock C
protects against catheter related infection
medCOMP

3. Duralock C medCOMP protects against catheter related infection
prevents the formation of biofilm
medCOMP

4. Duralock C medCOMP protects against catheter related infection
prevents the formation of biofilm
prevents catheter clotting  use of thrombolytic agents
medCOMP

5. Literature shows catheter related bacteremia incidence of
Duralock C
protects against catheter related infection
Literature shows catheter related bacteremia incidence of
3,0 – 7,0 episodes/1.000 cath.days
medCOMP

6. Literature shows catheter related bacteremia incidence of
Duralock C
protects against catheter related infection
Literature shows catheter related bacteremia incidence of
3,0 – 7,0 episodes/1.000 cath.days
Tunneled
Non tunneled
medCOMP

7. Duralock C medCOMP protects against catheter related infection
Most cultured microbes:
S. aureus
Coagulase negative s. aureus
S epidermidis
Candida albicans
E. Agglomerans
P. aeruginosa
Enterococcus faecalis
medCOMP

8. Duralock C medCOMP protects against catheter related infection
Consequenses of CRB:
Serious complications in the use of catheters
medCOMP

9. Duralock C medCOMP 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
medCOMP

10. Duralock C medCOMP 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
medCOMP

11. Duralock C medCOMP 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
medCOMP

12. Power of Duralock C medCOMP
protects against catheter related infection
medCOMP

13. Power of Duralock C medCOMP
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
medCOMP

14. Power of Duralock C medCOMP
protects against catheter related infection
Infection Rate
medCOMP

15. Power of Duralock C medCOMP
protects against catheter related infection
Trisodium citrate 30%
Heparin 5000 IU/ml
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee
medCOMP
Nephrol Dial Transplant (2002) 17: 2189–2195

16. Power of Duralock C medCOMP
Disk Diffusion Susceptibility Test
protects against catheter related infection
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee
medCOMP
Nephrol Dial Transplant (2002) 17: 2189–2195

17. Power of Duralock C medCOMP
protects against catheter related infection
Heparin 5000 IU/ml
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee
medCOMP
Nephrol Dial Transplant (2002) 17: 2189–2195

18. Study design Primary endpoint: Catheter survival Interimanalysis
Secondary endpoints
- infection - bacteremia
- exit site infection
- thrombosis - flow problems
- use of urokinase
- side effects - bleeding
- thrombocytopenia
- systemic reactions after locking
bacteremia

19. 291 hemodialysis catheters
citrate 30%
heparin
total
Catheters
tunneled cuffed
jugular
subclavian
femoral
untunneled
148 50 49 1 98 77 20
143 48 95 69 2 24
291 97
193
146 3
Catheter days
8431
8116
16547
Days per catheter
57.0
97.1
36.5
56.8
94.2
37.8
56.9
95.7
37.1
Aardig om te zien hoe weinig subclavia’s er worden gedaan.

20. Power of Duralock C medCOMP Why protects a citrate solution
against catheter related infections?
medCOMP

21. Power of Duralock C medCOMP Why protects a citrate solution
against catheter related infections?
Citrate = combined with
citric acid = C3H5O(COO)33−
binds
double positive ionized molecules: Ca++ / Mg++
Na3C6H5O7
medCOMP

22. Power of Duralock C medCOMP
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
medCOMP

23. Power of Duralock C medCOMP
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.”
M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee
medCOMP
Nephrol Dial Transplant (2002) 17: 2189–2195

24. Power of Duralock C medCOMP
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
medCOMP

25. Catheter survival
heparin
TSC
P=0.014
days in place
18%
medCOMP

26. medCOMP Bacteremia free survival 73% days in place TSC P=0.0002
heparin
TSC
days in place
73%
medCOMP

27. Infection related admissions
P=0.002
P=0.001
medCOMP

28. medCOMP 18 13 Mortality heparin citrate 30% overall P=0.35 P=0.022 20
P=0.022 5
Bacteremia related 20 18 16 18 14 12 13 10
heparin 8
citrate 30% 6 4 2
overall
medCOMP

29. Duralock C
Prevents formation of biofilm
medCOMP

30. Duralock C
Prevents formation of biofilm
Micro organisms
medCOMP

31. Duralock C medCOMP Prevents formation of biofilm
Biofilm grows under the influence of poly sacharides, produced by micro organisms.
medCOMP

32. Duralock C medCOMP 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
medCOMP

33. Duralock C medCOMP 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
medCOMP

34. Duralock C medCOMP Biofilms on indwelling vascular catheters, Method:
Crit Care Med May;20(5):
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.
medCOMP

35. Duralock C medCOMP Prevents formation of biofilm
Crit Care Med May;20(5):
Biofilms on indwelling vascular catheters,
Passerini. L, Lam K, Costerton JW, King EG
Conclusion:
Extensive biofilm formation on all 42 arterial and 26 central venous catheters.
Bacteria within the biofilms on 69% (29/42) of the arterial and 88% (23/26) of the central venous catheters.
medCOMP

36. Power of Duralock C medCOMP 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 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: /ndt/gfl170
medCOMP

37. Power of Duralock C medCOMP 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: /ndt/gfl170
medCOMP

38. Duralock C
prevents catheter clotting  use of thrombolytic agents
Catheter related thrombosis is often the cause of low catheter blood flows.
medCOMP

39. Low blood flow  inefficient treatment  low Kt/V
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

40. Low blood flow  inefficient treatment  low Kt/V
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)
medCOMP

41. Power of Duralock C medCOMP
prevents catheter clotting  use of thrombolytic agents
Under influence of
Ca++
So...
medCOMP

42. Power of Duralock C medCOMP
prevents catheter clotting  use of thrombolytic agents
Under influence of
Ca++
So...
Binding Ca++ in the catheter environment,
stops the proces of clotting
medCOMP

43. getunneld = ongetunneld
Flow problems
heparin
TSC
P=0.754
days in place
Tegen verwachting in beetje, zeker tegen verwachting van fabrikanten van andere opvulvloeistoffen. Zelf wel gedacht, pathofysiologie van aanvoerproblemen waarschijnlijjk meer in sheet formatie aan buitenkant katheter
getunneld = ongetunneld
medCOMP

44. Power of Duralock C medCOMP
prevents catheter clotting  use of thrombolytic agents
medCOMP
Ash SR, et al. ASN 1999 A1375

45. Duralock C medCOMP Leakage lock solution Bleeding complications
Hierbij 1 uur na de dialyse APTT gemeten, citraat 46% vs heparine 5000E/ml, Inmiddels ook berichten dat het daadwerkelijk meer bloedingen geeft.
medCOMP
Bayes B et al, Nephrol Dial Transpl 1999; 14; 2532

46. Power of Duralock C medCOMP
protects against catheter related infection
Sodium citrate for filling haemodialysis catheters
“We recommend filling the catheter with sodium citrate 46,7%
medCOMP
Bayes B et al, Nephrol Dial Transpl 1999; 14; 2532

47. Duralock C medCOMP Bleeding complications
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:
medCOMP

48. Consequences of leakage lock solution
Bleeding complications during citrate-trial
P=0.005
P=0.01 16 5
During follow up 20
heparin 18 19
citrate 30% 16 14 12 10
Betreft met een verschil in belangrijke GI-bloedingen. Bloeding was gedefinieerd; HP-bloeding die dusdanig was dat patiënt langer op de afdeling moest verblijven dan gepland of dat pat terugkwam naar centrum wegens nabloeden. Tijdens followup was het: klinisch relevante bloeding: HB-daling van meer dan 2 punten of als transfusie noodzakelijk was. 8 6 6 4 2
After insertion
medCOMP

49. 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 (2):
medCOMP

50. Anti microbial protection, Weijmer)
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%
Anti microbial protection, Weijmer)
30%
30%
medCOMP

51. Duralock C medCOMP Literature reviews: 51
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
medCOMP 51

52. Duralock C medCOMP Heparin Anticoagulant Systemic effect
Generates bleeding risks
Promotes bacterial growth, poly sacharide is feed for micro organisms
medCOMP

53. Duralock C medCOMP Heparin Anticoagulant Systemic effect
Generates bleeding risks
Promotes bacterial growth, poly sacharide is feed for micro organisms
Promotes formation of biofilm
medCOMP

54. Power of Duralock C medCOMP Conclusions:
Trisodium citrate, in a concentration of at least 30% shows an antimicrobial effect (Weijmer et al)
Trisodium citrate 30% shows a decrease of CRB of 75% in a randomized controlled multi centre trial (Weijmer et al).
Trisodium citrate 30% doesn’t effect positively on blood flow and use of thrombolytic agents (Weijmer et al)
Trisodium citrate 46,7% does show in In vivo studies a decrease in CRB and use of thrombolytic agents like Urokinase.
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.
Catheter lock solutions based on antibiotics promote the risk of anti biotic resistance.
medCOMP

55. DURALOCK C medCOMP 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

56. 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
התחלת אבלואציות במחלקות הנפרולוגיה
המשך צפייה בפרוצדורות המחלקות האנגיו- שעות 14:00-17:00

57. Action plan- january 25-29.1 .118-22 מצגת קטטרים לטווח קצר- 26.1.09
מצגת דורה לוק
הצגת דף הסבר דורה לוק
המשך צפייה בפרוצדורות המחלקות האנגיו- שעות 8:00-12:00
תיאום פגישות עם הרופאים הרלוונטים- 29.1

58. Action plan- march
8-12.3
1-5.3
הוצאת דרישות למוצר מול מחלקות הרכש
ליווי אבלואציות במחלקות הנפרולוגיה
מעקב אחר הזמנות למוצר מול מחלקות הרכש
הנפקת הצעות מחיר למנהלי מחלקות הנפרולוגיה
השתלבות במחלקות האנגיו הרלוונטיות וחפיפה על הלקוח+ היכרויות עם מנהלי היחידות.

59. DURALOCK C
Q & A
medCOMP