NCT07567456

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
591

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

Study Start

First participant enrolled

February 2, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Haemodialysis PatientsBlockage of Tunnelled Central Venous Access DevicePulsatile Flushing Technique

Keywords

HDT-CVADPulsatile Flushing Technique

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (3)

Intervention Group A

EXPERIMENTAL

Use of pulsatile flushing technique (0.4s pause interval)

Other: Pulsatile Flushing Technique (0.4s pause interval)

Intervention Group B

EXPERIMENTAL

Use of pulsatile flushing technique (1s pause interval)

Other: Pulsatile Flushing Technique (1s pause interval)

Control Group

ACTIVE COMPARATOR

Standard bolus flushing technique

Other: Bolus Flushing Technique

Interventions

Pulsatile Flushing Technique (0.4s pause interval)OTHER

Pulsatile flushing technique consists of multiple small boluses injected intermittently with 0.4-second pauses between each bolus resulting in unsteady turbulent flow.

Intervention Group A
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.

Intervention Group B
Bolus Flushing TechniqueOTHER

Bolus flushing technique involves the continuous administration of a single, concentrated volume of flush solution resulting in consistent laminar flow

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Elizabeth Hospital

Kowloon, Hong Kong

RECRUITING

Related Publications (15)

  • 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.

    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.

    PMID: 21748725BACKGROUND

  • J. Mehta, H. (2021). Hemodialysis Vascular Access with Central Venous Disease. IntechOpen. doi: 10.5772/intechopen.9303

    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.

    PMID: 30589719BACKGROUND

  • 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.

    PMID: 38477478BACKGROUND

  • World Health Organization. (n.d.). Cluster Randomized Trials 4.3. In WHO Guidance on Research Methods for Health-EDRM (pp. 266-270).

    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.

    PMID: 8912825BACKGROUND

  • 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.

    PMID: 26322512BACKGROUND

  • 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.

    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.

    PMID: 32778223BACKGROUND

  • 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.

    BACKGROUND

Central Study Contacts

SUNG Ka Ming Dorothy, KCC NC (Renal Care)

CONTACT

852-3506bskmd01@ha.org.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Paralleled Cluster Non-Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Consultant (Renal Care)

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)