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| Name | Class |
|---|---|
| Kwong Wah Hospital | OTHER |
| Prince of Wales Hospital, Shatin, Hong Kong | OTHER |
| Alice Ho Miu Ling Nethersole Hospital | OTHER |
| North District Hospital, Hong Kong |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group A | Experimental | Use of pulsatile flushing technique (0.4s pause interval) |
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| Intervention Group B | Experimental | Use of pulsatile flushing technique (1s pause interval) |
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| Control Group | Active Comparator | Standard bolus flushing technique |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsatile Flushing Technique (0.4s pause interval) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-event T-CVAD Blockage | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SUNG Ka Ming Dorothy, KCC NC (Renal Care) | Contact | 852-3506 | 6507 | bskmd01@ha.org.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | Recruiting | Kowloon | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 21748725 | Background | 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. | |
| Background | J. Mehta, H. (2021). Hemodialysis Vascular Access with Central Venous Disease. IntechOpen. doi: 10.5772/intechopen.9303 | ||
| 30589719 |
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| UNKNOWN |
| Caritas Medical Centre, Hong Kong | OTHER |
| Queen Mary Hospital, Hong Kong | OTHER |
| Tseung Kwan O Hospital, Hong Kong | OTHER |
| Tin Shui Wai Hospital | UNKNOWN |
| Yan Chai Hospital | OTHER |
| Tung Wah Hospital | OTHER |
| Pamela Youde Nethersole Eastern Hospital | OTHER |
| Tuen Mun Hospital | OTHER_GOV |
| Princess Margaret Hospital, Hong Kong | OTHER_GOV |
Paralleled Cluster Non-Randomized Controlled Trial
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| Pulsatile Flushing Technique (1s pause interval) | Other | 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). |
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| Bolus Flushing Technique | Device | Bolus flushing technique involves the continuous administration of a single, concentrated volume of flush solution resulting in consistent laminar flow |
|
| Background |
| Boord C. Pulsatile Flushing: A Review of the Literature. J Infus Nurs. 2019 Jan/Feb;42(1):37-43. doi: 10.1097/NAN.0000000000000311. |
| 38477478 | Background | 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. |
| Background | World Health Organization. (n.d.). Cluster Randomized Trials 4.3. In WHO Guidance on Research Methods for Health-EDRM (pp. 266-270). |
| 8912825 | Background | 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. |
| 26322512 | Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | CDC. (2020). Guidelines for the Prevention and Treatment of Catheter-Related Bloodstream Infections. Centers for Disease Control and Prevention. |
| 32778223 | Background | 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. |
| Background | 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. |
| Background | 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. |
| Background | 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. |