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There is evidence that central venous catheters made of the permanent and non-eluting integral polymer Endexo® are more resistant to intraluminal thrombosis. This has a direct reducing effect on catheter malfunctions. Indirectly, due to reduced handling of the dysfunctional catheter, this may lead to a diminished rate of catheter related infections. Since catheter malfunctions and infections represent leading complications in a dialysis population, dialysis catheters produced with Endexo® technology have the potential to have beneficial clinical effects. In addition to improving patient outcomes, this could also reduce overall costs. In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment | Active Comparator | Study participants will be recruited among those patients with the need of insertion of a tunneled catheter to perform hemodialysis who attend the recruitment site (Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis) for routine care. A tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be implanted. As a standard catheter lock solution 4% citrate (applied in each of the 2 lumens after each dialysis session) will be used. Care of the tunneled catheter in the study sites will be followed established standards including dressing changes, exit site care and hygiene. After each hemodialysis session the exit site will be inspected and covered with 2.0% chlorhexidine dressing (Tegaderm CHG, 3M, Neuss, Germany). Chronic haemodialyisis treatment will be held in a regular setting based on the patient's dialysis requirements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion of a tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) | Device | In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population. |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter dysfunction | Catheter dysfunction will be defined as inadequate blood flow during dialysis (blood flow < 200mL/min or >30% less than the average of the previous 10 sessions) and if present before or during dialysis, patient repositioning or reversal of catheter lines will be performed. If not successful, Taurolock Urokinase with a final Urokinase of 50.000 IU will be instilled per lumen either with a 30-minute dwell time before dialysis or as CLS in the inter-dialytic time as rescue. If urokinase is not effective after repeated use the dialysis catheter will be removed. | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Need for reversal of catheter lines | From enrollment to the end of treatment at 6 months | |
| Rescue with high dose urokinase (50.000 IU per lumen) | From enrollment to the end of treatment at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gürkan Sengölge, Assoc. Prof | Contact | +43 1 40400 43890 | guerkan.sengoelge@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28890326 | Background | Winnicki W, Herkner H, Lorenz M, Handisurya A, Kikic Z, Bielesz B, Schairer B, Reiter T, Eskandary F, Sunder-Plassmann G, Sengoelge G. Taurolidine-based catheter lock regimen significantly reduces overall costs, infection, and dysfunction rates of tunneled hemodialysis catheters. Kidney Int. 2018 Mar;93(3):753-760. doi: 10.1016/j.kint.2017.06.026. Epub 2017 Sep 8. | |
| 29649341 |
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|
| Total number of catheter-related infections | Catheter-related infections will be defined as positive bacterial blood culture drawn from the dialysis catheter in a symptomatic patient with fever or chills associated with dialysis and no apparent other source of infection. Blood cultures will be taken using aseptic technique from each lumen of the tunneled catheter and in addition from a peripheral vein whenever possible to determine the differential time to positivity. | From enrollment to the end of treatment at 6 months |
| Catheter-related infections free survival | From enrollment to the end of treatment at 6 months |
| Episodes of antibiotic therapy | From enrollment to the end of treatment at 6 months |
| Hospitalization days for catheter-related infectious event | From enrollment to the end of treatment at 6 months |
| Hospitalization for all-cause infectious event | From enrollment to the end of treatment at 6 months |
| Catheter removal due to infectious and mechanical complication | From enrollment to the end of treatment at 6 months |
| Exit-site or tunnel infection | Exit site infections will be defined as culturepositive inflammation localized to the exit site, not extending above the cuff. Tunnel infection is defined as culture-positive inflammation within the catheter tunnel internal to the cuff | From enrollment to the end of treatment at 6 months |
| Catheter renewal | From enrollment to the end of treatment at 6 months |
| Determine whether Endexo® catheters demonstrate biofilm formation | Explanted catheters (distal tip, intraluminal segments) will be sent to MoKi Analytics GmbH for assessment of biofilm formation using fluorescence in situ hybridization (FISH) according to validated SOPs. | From enrollment to the end of treatment at 6 months |
| Kleidon T, Ullman AJ, Zhang L, Mihala G, Chaseling B, Schoutrop J, Rickard CM. How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics. J Hosp Med. 2018 Aug 1;13(8):517-525. doi: 10.12788/jhm.2911. Epub 2018 Feb 8. |
| 35210738 | Background | El Khudari H, Ozen M, Kowalczyk B, Bassuner J, Almehmi A. Hemodialysis Catheters: Update on Types, Outcomes, Designs and Complications. Semin Intervent Radiol. 2022 Feb 18;39(1):90-102. doi: 10.1055/s-0042-1742346. eCollection 2022 Feb. |
| 11128425 | Background | Butterly DW, Schwab SJ. Dialysis access infections. Curr Opin Nephrol Hypertens. 2000 Nov;9(6):631-5. doi: 10.1097/00041552-200011000-00007. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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