Pulsatile Flushing Technique in Reducing Blockage of T-CVAD for Haemodialysis Patients (Non-RCT HD)
5 maj 2026 uppdaterad av: SUNG Ka Ming Dorothy, Queen Elizabeth Hospital, Hong Kong
Exploring the Effectiveness of Pulsatile Flushing Technique in Reducing Blockage of the Tunnelled Central Venous Access Device Among Haemodialysis Patients in Multiple Renal Centres in Hong Kong: A Cluster Non-Randomised Controlled Trial Study
This study investigates the effectiveness of pulsatile flushing techniques in reducing blockage in Tunnelled Central Venous Access Device (T-CVAD) among patients undergoing haemodialysis (HD) treatment at multiple renal centres within the Hospital Authority (HA) in Hong Kong.
With limitation in single service protocol for each cluster of renal units, it is designed as a prospective, parallel, cluster non-randomised controlled trial involving 591 patients from 14 renal units.
In order to identify the most effective flushing technique for T-CVAD maintenance, survival analysis on clinical effectiveness, in terms time-to-event blockage of the T-CVAD, among three trial arms: 1) Intervention Group A (IG-A) using pulsatile flushing technique with 0.4 second pause time interval; 2) Intervention Group B (IG-B) using pulsatile flushing technique with 1 second pause time interval; 3) Control Group (Con) using standard bolus flushing technique.
The findings facilitate development of best practice for T-CVAD maintenance, optimise T-CVAD maintenance protocols, and ultimately improve patient outcomes.
This groundbreaking study is expected to signify substantial progression in the nursing management of HD and T-CVAD.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
591
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: SUNG Ka Ming Dorothy, KCC NC (Renal Care)
- Telefonnummer: 6507 852-3506
- E-post: bskmd01@ha.org.hk
Studieorter
-
-
-
Kowloon, Hong Kong
- Rekrytering
- Queen Elizabeth Hospital
-
Kontakt:
- Ka Ming Dorothy SUNG, KCC NC (Renal Care)
- Telefonnummer: 6507 852-3506
- E-post: bskmd01@ha.org.hk
-
Huvudutredare:
- Ka Ming Dorothy SUNG, KCC NC (Renal Care)
-
Underutredare:
- Kai Cheong Harris LAM, HOCS M(N)/ CNO
-
Underutredare:
- Suet Lai TAM, KWH NC (Renal Care)
-
Underutredare:
- Ngar Yee CHOW, NTEC NC (Renal Care)
-
Underutredare:
- Hau Sim Eva HO, HKEC NC (Renal Care)
-
Underutredare:
- May Ki LAM, QMH NC (Renal Care)
-
Underutredare:
- Lai Nga PO, NTWC NC (Renal Care)
-
Underutredare:
- Shuk Hang LEE, KWC & PMH NC (Renal Care)
-
Underutredare:
- Har Ping CHEUNG, TKOH APN (MED)
-
Underutredare:
- Victor CHEUNG, QEH EOII (MDSSC)
-
-
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:
- Patients undergoing HD treatment with Tunnelled Central Venous Access Device (T-CVAD) in the above collaborators under the Hospital Authority
- Able to understand spoken and written Chinese or English
Exclusion Criteria:
- Patients with Non-Tunnelled Central Venous Access Device (NT-CVAD)
- Temporary dysfunction (e.g., kicking of the catheter) resolved with repositioning
- Confirmed case of fibrin sheath occlusion which can only be resolved through surgical intervention
- Non-thrombotic occlusion due to mechanical causes (e.g., catheter malposition)
- Patient declined or incompetent to provide written informed consent.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention Group A
Use of pulsatile flushing technique (0.4s pause interval)
|
Pulsatile flushing technique consists of multiple small boluses injected intermittently with 0.4-second pauses between each bolus resulting in unsteady turbulent flow, performed by a renal nurse who passed a formal train-the-trainer program on "pulsatile flushing technique" taught and assessed by designated nurse consultant (renal care).
Andra namn:
|
|
Experimentell: Intervention Group B
Use of pulsatile flushing technique (1s pause interval)
|
Pulsatile flushing technique consists of multiple small boluses injected intermittently with 1-second pauses between each bolus resulting in unsteady turbulent flow, performed by a renal nurse who passed a formal train-the-trainer program on "pulsatile flushing technique" taught and assessed by designated nurse consultant (renal care).
Andra namn:
|
|
Aktiv komparator: Control Group
Standard bolus flushing technique
|
Bolus flushing technique involves the continuous administration of a single, concentrated volume of flush solution resulting in consistent laminar flow
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time-to-event T-CVAD Blockage
Tidsram: From the date of recruitment until the end of the study (at least 1-year follow-up) or date of termination (e.g., blockage, death, refusal to participate in the study… etc) whichever comes earlier, assessed up to 24 months.
|
as measured by time to the first occurrence of blockage of Tunnelled Central Venous Access Device (T-CVAD).
T-CVAD blockage episodes can be transformed to incidence rates (in episodes per patient-year), or presented by Kaplan-Meier analysis with median blockage-free survival statistics stratified by three trial arms.
|
From the date of recruitment until the end of the study (at least 1-year follow-up) or date of termination (e.g., blockage, death, refusal to participate in the study… etc) whichever comes earlier, assessed up to 24 months.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
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
- Guiffant G, Durussel JJ, Merckx J, Flaud P, Vigier JP, Mousset P. Flushing of intravascular access devices (IVADs) - efficacy of pulsed and continuous infusions. J Vasc Access. 2012 Jan-Mar;13(1):75-8. doi: 10.5301/JVA.2011.8487.
- Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, Allon M, Asif A, Astor BC, Glickman MH, Graham J, Moist LM, Rajan DK, Roberts C, Vachharajani TJ, Valentini RP; National Kidney Foundation. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020 Apr;75(4 Suppl 2):S1-S164. doi: 10.1053/j.ajkd.2019.12.001. Epub 2020 Mar 12.
- Chan, P. S., Lee, M., & Au WN et al. (2024). Evidence-based Practice Review of Haemodialysis Catheter Flushing Technique in NTWC Renal Units. Retrieved from the Poster Presentation, HA Convention, HKSAR.
- J. Mehta, H. (2021). Hemodialysis Vascular Access with Central Venous Disease. IntechOpen. doi: 10.5772/intechopen.9303
- Boord C. Pulsatile Flushing: A Review of the Literature. J Infus Nurs. 2019 Jan/Feb;42(1):37-43. doi: 10.1097/NAN.0000000000000311.
- Giraudeau B, Weijer C, Eldridge SM, Hemming K, Taljaard M. Why and when should we cluster randomize? J Epidemiol Popul Health. 2024 Feb;72(1):202197. doi: 10.1016/j.jeph.2024.202197. Epub 2024 Feb 9.
- World Health Organization. (n.d.). Cluster Randomized Trials 4.3. In WHO Guidance on Research Methods for Health-EDRM (pp. 266-270).
- Geller SA, Nichols WS, Rojter SE, Chan RC, Petrovic LM, Vierling JM, Makowka L. Hepatitis C virus is not recoverable from liver tissue in cryptogenic cirrhosis: failure to identify hepatitis C virus-RNA using reverse transcription-mediated polymerase chain reaction. Hum Pathol. 1996 Nov;27(11):1161-5. doi: 10.1016/s0046-8177(96)90309-3.
- Wolf J, Tang L, Rubnitz JE, Brennan RC, Shook DR, Stokes DC, Monagle P, Curtis N, Worth LJ, Allison K, Sun Y, Flynn PM. Monitoring Central Venous Catheter Resistance to Predict Imminent Occlusion: A Prospective Pilot Study. PLoS One. 2015 Aug 31;10(8):e0135904. doi: 10.1371/journal.pone.0135904. eCollection 2015.
- Patel, A. S., et al. (2019). Pulsatile flushing reduces catheter-related bloodstream infections in patients with tunnel central venous catheters. Journal of Vascular Access, 20(1), 49-56.
- Lee, J. H., et al. (2020). Pulsatile flushing reduces biofilm formation and infection rate in patients with tunnel central venous catheters. Journal of Vascular Access, 21(2), 147-155.
- CDC. (2020). Guidelines for the Prevention and Treatment of Catheter-Related Bloodstream Infections. Centers for Disease Control and Prevention.
- Li, X., et al. (2020). Incidence of tunnel central venous catheter occlusion in hemodialysis patients: A multicenter study in Hong Kong. Journal of Vascular Access, 21(3), 249-257.
- Van Rij, A. M., et al. (2018). Pulsatile flushing to prevent central venous catheter occlusion in patients with cancer. Journal of Vascular Access, 19(3), 257-265.
- Mueller, S. W., et al. (2019). Pulsatile flushing to prevent central venous catheter occlusion in patients with long-term central venous access devices. Journal of Vascular Access, 20(3), 245-253.
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 (Faktisk)
2 februari 2026
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
1 december 2027
Studieregistreringsdatum
Först inskickad
28 april 2026
Först inskickad som uppfyllde QC-kriterierna
28 april 2026
Första postat (Faktisk)
5 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CIRB-2025-277-1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .