Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters
11 juni 2026 uppdaterad av: Guerkan SENGOELGE, Medical University of Vienna
Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters (Silicone or Polyurethane): A Pilot Study
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Gürkan Sengölge, Assoc. Prof
- Telefonnummer: +43 1 40400 43890
- E-post: guerkan.sengoelge@meduniwien.ac.at
Studieorter
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Vienna, Österrike
- Medical University of Vienna
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Kontakt:
- Gürkan Sengölge, Assoc. Prof.
- Telefonnummer: +43 1 40400-43890
- E-post: guerkan.sengoelge@meduniwien.ac.at
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Adult patients aged greater than 18 years
- Written informed consent
- Requirement for hemodialysis using a tunneled dialysis catheter
Exclusion Criteria:
- Children aged less than 18 years
- Uncontrolled infection; defined as positive blood culture in the past seven days before catheter insertion and/ or elevated C-reactive protein [CRP >5 mg/dl (normal <0.5 mg/dl)] at screening
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Insertion of a tunneled hemodialysis catheter with Endexo® technology for haemodialysis treatment
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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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Catheter dysfunction
Tidsram: From enrollment to the end of treatment at 6 months
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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.
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From enrollment to the end of treatment at 6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Need for reversal of catheter lines
Tidsram: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Rescue with high dose urokinase (50.000 IU per lumen)
Tidsram: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Total number of catheter-related infections
Tidsram: From enrollment to the end of treatment at 6 months
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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.
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From enrollment to the end of treatment at 6 months
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Catheter-related infections free survival
Tidsram: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Episodes of antibiotic therapy
Tidsram: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Hospitalization days for catheter-related infectious event
Tidsram: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Hospitalization for all-cause infectious event
Tidsram: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Catheter removal due to infectious and mechanical complication
Tidsram: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Exit-site or tunnel infection
Tidsram: From enrollment to the end of treatment at 6 months
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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
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From enrollment to the end of treatment at 6 months
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Catheter renewal
Tidsram: From enrollment to the end of treatment at 6 months
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From enrollment to the end of treatment at 6 months
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Determine whether Endexo® catheters demonstrate biofilm formation
Tidsram: From enrollment to the end of treatment at 6 months
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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.
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From enrollment to the end of treatment at 6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- Butterly DW, Schwab SJ. Dialysis access infections. Curr Opin Nephrol Hypertens. 2000 Nov;9(6):631-5. doi: 10.1097/00041552-200011000-00007.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
1 augusti 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
11 juni 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
18 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2026
Senast verifierad
1 mars 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Njurinsufficiens, kronisk
Andra studie-ID-nummer
- 1987/2025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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Ja
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