preventionof lumen occlusion

Transcription

1 what s new in prevention of non-infective complications? preventionof lumen occlusion RYDER SCIENCE, Inc..medical biofilm research Marcia Ryder PhD MS RN

2 original research presented in this presentation was funded by Abiotic Technologies. the investigators retained control of the design, conduct, analysis and presentation of these studies

3 causes of catheter occlusion blood reflux / needleless connectors inadequate flushing fibrin sheath / tail mechanical obstruction blood reflux / flucuatons in SVC venous pressure drug precipitate what s new?

4 blood reflux / needleless connectors CRITICAL DESIGN FEATURES 1. ACCESS MECHANISMS 2. FLOW PATH 3. FLUID DISPLACEMENT

5 displacement NEGATIVE DISPLACEMENT POSITIVE / NEUTRAL DISPLACEMENT NO DISPLACEMENT / ANTI-REFLUX

6 negative positive neutral anti-reflux

7 CS MP US MZ BS OL QS

8 Elli S, et al. JVA. 2016;17(5): purpose to evaluate fluid reflux inside the catheter, when disconnecting syringes, for different needleless connectors with either negative, neutral or positive displacement to develop a table of the expected blood reflux inside the catheter, in relation to catheter calibers

9 sample size Pos Neu Neu 9 connectors 2 catheters 14, 16, 18, 20, 22g MaxZero Microclave clear Bionectuer A-R Neg Neg Neutron SmartSite Safe Plus Neu A-R Neu NeutraClear NeutroX Dasa Elli S, et al. JVA. 2016;17(5):429-34

10 methods connector/catheter flushed with 10 ml blue dye and disconnected retraction of fluid into catheter measured (mm) flushes completed by clinicians (9 nurses, 3 physicians) Elli S, et al. JVA. 2016;17(5):429-34

11 results NEG A-R NEU NEU P Elli S, et al. JVA. 2016;17(5):429-34

12 results: Elli S, et al. JVA. 2016;17(5):429-34

13 inadequate flushing definitions flush: a manual injection of 0.9% normal saline to clean the catheter lock: the injection of a limited volume of liquid following the catheter flush, for the period of time when the catheter is not used Goossens AG. Nursing Research PracA. 2015;2015:1-12

14 Flushing and Locking the lumen..consider the solutions! definitions lock / flush: the injection of a limited volume of liquid following the catheter flush, for the period of time when the catheter is not used; can be infused rather than aspirated at the end of required time period Goossens AG. Nursing Research PracA. 2015;2015:1-12

15 Flushing and Locking the lumen..consider the solutions! what should the lock solution do? prevent lumen occlusion prevent bacterial colonization Pittiruti M, et al. JVA. 2016;17(6):

16 study design systematic literature review expert panel concensus question 1 Is there a role for anticoagulant lock in the management of non-dialysis central venous access (NDCVA), as a method for prevention of lumen occlusion? Pittiruti M, et al. JVA. 2016;17(6):

17 key points there is no evidence that the efficacy of heparin lock might be dose or concentration dependent use of heparin or other anticoagulant drugs may increase the risk of undesired side effects and/or severe iatrogenic complications the role of anticoagulant lock is only marginally important in the management of NDCVA, in terms of prevention of lumen occlusion the risk of occlusion is currently considered to be related to inappropriate policies of flushing and use of needleless connectors that allow reflux of blood into the catheter (use of neutral, positive or no-reflux connector recommended Pittiruti M, et al. JVA. 2016;17(6):

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19 question 2 which drug (heparin, citrate, urokinase, rtpa, etc.) may have a primary role in this kind of lock? Pittiruti M, et al. JVA. 2016;17(6):

20 key points 5 anticoagulants considered: heparin, urokinase, trisodium citrate, rtpa, EDTA there are relevant studies to support anticoagulant efficacy of heparin or citrate for locking in DCVC citrate >4% should not be used for catheter locking due to potential serious side effects of high doses there is scarce clinical data regarding the use of EDTA in catheter locks, but the preliminary results are promising Pittiruti M, et al. JVA. 2016;17(6):

21 question 3 is there evidence that lock with normal saline might be as appropriate as an anticoagulant lock, in terms of prevention of lumen occlusion? recommendations saline lock is as appropriate as anticoagulant lock in the prevention of occlusion of NDCVC Pittiruti M, et al. JVA. 2016;17(6):

22 question 4 Is there any evidence about the most appropriate flushing method with saline before any kind of lock? recommendations a pulsatile positive push and pause ( start and stop ) technique is the most appropriate methodology of flushing Pittiruti M, et al. JVA. 2016;17(6):

23 purpose to compare the efficacy of pulsed and continuous infusion for flushing CVCs methods preconditioned catheters with fibronectin and bovine albumin compared different flow rates, flushing volumes and time intervals normal saline infusions / flushes via infusion pump Guiffant G, et al. J Vasc Access. 2012;13:75-78

24 methods compared continuous infusion 500 ml / 24 h single 10 ml bolus / 6 flushing times (2.5, 5, 10, 20, 40, 60 sec) 10 successive boluses 1 ml flushed 0.5 sec each / 6 time intervals between boluses (0.1, 0.2, 0.4, 0.5, 0.6, and 0.8 sec) measured amount of albumin recovered from the catheter lumen Guiffant G, et al. J Vasc Access. 2012;13:75-78

25 results maximun efficacy (90 +/- 3%) with pulsatile flushing at 0.4 second intervals flow type and time intervals between 2 boluses are 2 critical variables Guiffant G, et al. J Vasc Access. 2012;13:75-78

26 purpose to demonstrate the advantage of using pulsatile flushing technique in preventing the accumulation of bacteria on the endoluminal wall, before biofilm formation Ferroni A, et al. Med Devices: evidence and research. 2014;7:379-83

27 study design Ferroni A, et al. Med Devices: evidence and research. 2014;7:379-83

28 results conclusion pulsatile flushing appears to be efficient in reducing catheter bacterial colonization to prevent bacteremia Ferroni A, et al. Med Devices: evidence and research. 2014;7:379-83

29 question 5 is there a role for antimicrobial agents in the lock of NDCVC, as a method for prevention of catheter colonization or CRBSI? Pittiruti M, et al. JVA. 2016;17(6):

30 recommendations while ethanol lock is highly effective, due to concerns about its safety, the drugs most likely to be used as antibacterial lock are taurolidine and citrate, which have optimal characteristics in terms of safety, efficacy and cost effectiveness non-antibiotic antibacterial lock will have a major future role for prevention of catheter colonization and infection Pittiruti M, et al. JVA. 2016;17(6):

31 question 7 Is there any anticoagulant/antimicrobial association that may have a role for the lock of NDCVC? what s new? Pittiruti M, et al. JVA. 2016;17(6):

32 what is tedta? Na 2- O 2 CH 2 C CH 2 CO 2- Na 2 NH 2 C CH 2 N Di-sodium EDTA Na2-O 2 CH 2 C CH 2 CO 2 -Na2 NH 2 C CH 2 N Na 2- O 2 CH 2 C CH 2 CO 2- Na 2 Tetra-sodium EDTA

33 characteristics of tedta metabolism not metabolized excreted primarily by the kidney half-life ~ 65 min (50% in 65 min, 99% in ~7.6 antimicrobial antimicrobial and anti-biofilm chelation of metals (primarily Ca and Mg) anticoagulant

34 a chilling reality!

35 purpose to evaluate tedta lock solution for killing and removal of biofilms formed within vascular catheters by antibiotic resistance organisms study design Ryder M, DeLancy-Pulcini E, Parker A, James G in vitro experimental control group: normal saline lock treatment group[: 2% tedta in saline

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37 MC-XXXXXX assemble catheter with connector MC-XXXXXX pre-condition with de-complemented adult bovine serum incubate overnight DAY 1 inoculate with suspension MRSA 10 6 cfu/ml in nutrient incubate 2 hr flush with fresh nutrient incubate 6 hr flush with fresh nutrient incubate 16 hr fill catheter with NS(3) or tedta 2% (3) sample 3cm catheter segments at 0, 4, 8, 24 (fresh lock), 32 hr 3 experiments

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39 results

40 results

41 Gram negative K pneumoniae CRE E coli ESBL P aeruginosa MDR A baumannii MDR conclusion: Gram positive S aureus MRSA E faecalis VRE the 2% tedta lock/flush solution significantly reduced a greater than 10 5 intraluminal biofilm over a 24 hour time period and completely eradicated a 10 5 intraluminal biofilm by 32 hours in the six antibiotic resistant test organisms tested to date. these results suggest that the 2% tedta lock/flush solution may have a significant impact on the reduction of antibiotic resistant CRBSI events in vascular catheters.

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43 protective technologies for prevention of bacterial transfer access site disinfection low bacterial transfer needleless connector antimicrobial/ anticoagulant lock flush ELD 96 hr (0.2 micron) bacteria retentive endotoxin retentive air eliminating particulate retentive catheter hub disinfection antimicrobial catheter