Haemodialysis PatientsNon-RCT HDNCT07567456

Pulsatile Flushing Technique in Reducing Blockage of T-CVAD for Haemodialysis Patients

A study testing Pulsatile Flushing Technique (0.4s pause interval), Pulsatile Flushing Technique (1s pause interval) and Bolus Flushing Technique in people with Haemodialysis Patients and Blockage of Tunnelled Central Venous Access Device, run by Queen Elizabeth Hospital, Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Haemodialysis Patients, Blockage of Tunnelled Central Venous Access Device, Pulsatile Flushing Technique
What is being tested?: Pulsatile Flushing Technique (0.4s pause interval), Pulsatile Flushing Technique (1s pause interval) and Bolus Flushing Technique
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 591 participants
Where: 1 siteHong Kong
Study dates: 2 Feb 2026to Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

SUNG Ka Ming Dorothy, KCC NC (Renal Care) contact

852-3506 ext. 6507

bskmd01@ha.org.hk

Hong Kong1 site, 1 recruiting

Queen Elizabeth Hospital
Kowloon
Ka Ming Dorothy SUNG, KCC NC (Renal Care), 852-3506 ext. 6507, bskmd01@ha.org.hk
Ka Ming Dorothy SUNG, KCC NC (Renal Care)
Recruiting

Other trials in Hong Kong

About this study

Official title: 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.

Conditions: Haemodialysis Patients, Blockage of Tunnelled Central Venous Access Device, Pulsatile Flushing Technique
Being tested: Pulsatile Flushing Technique (0.4s pause interval), Pulsatile Flushing Technique (1s pause interval), Bolus Flushing Technique
Keywords: HD, T-CVAD, Pulsatile Flushing Technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulsatile Flushing Technique (0.4s pause interval)Device
Also called Catheter Care Simulation System
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).
Pulsatile Flushing Technique (1s pause interval)Other
Also called Catheter Care Simulation System
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).
Bolus Flushing TechniqueDevice
Bolus flushing technique involves the continuous administration of a single, concentrated volume of flush solution resulting in consistent laminar flow

Study groups in NCT07567456
Study group	Role	What they receive
Intervention Group A	Experimental	Use of pulsatile flushing technique (0.4s pause interval) Receives: Device: Pulsatile Flushing Technique (0.4s pause interval)
Intervention Group B	Experimental	Use of pulsatile flushing technique (1s pause interval) Receives: Other: Pulsatile Flushing Technique (1s pause interval)
Control Group	Active comparator	Standard bolus flushing technique Receives: Device: Bolus Flushing Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 2026Dec 2027

First posted5 May 2026
Study start2 Feb 2026
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Haemodialysis PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Paralleled Cluster Non-Randomized Controlled Trial
Masking: None (open label)
Enrolment: 591 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07567456
Sponsor's protocol ID: CIRB-2025-277-1
Acronym: Non-RCT HD
Status last verified: Apr 2026
First submitted: 28 Apr 2026
Last updated: 11 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
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.
PubMed 21748725
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.
PubMed 30589719
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.
PubMed 38477478
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.
PubMed 8912825
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.
PubMed 26322512
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.
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.
PubMed 32778223
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.

Interested in taking part?

SUNG Ka Ming Dorothy, KCC NC (Renal Care)

852-3506 ext. 6507

bskmd01@ha.org.hk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Haemodialysis Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07567456
Acronym / sponsor ID: Non-RCT HD / CIRB-2025-277-1
Conditions: Haemodialysis Patients, Blockage of Tunnelled Central Venous Access Device, Pulsatile Flushing Technique
Keywords: HD, T-CVAD, Pulsatile Flushing Technique
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 591 participants (estimated)
Lead sponsor: Queen Elizabeth Hospital, Hong KongUniversity, hospital or other
Collaborators: Kwong Wah Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Alice Ho Miu Ling Nethersole Hospital, North District Hospital, Caritas Medical Centre, Hong Kong, Queen Mary Hospital, Hong Kong, Tseung Kwan O Hospital, Hong Kong, Tin Shui Wai Hospital, Yan Chai Hospital, Tung Wah Hospital, Pamela Youde Nethersole Eastern Hospital, Tuen Mun Hospital, Princess Margaret Hospital, Hong Kong
Study start: 2 Feb 2026 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 5 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Paralleled Cluster Non-Randomized Controlled Trial

Arm	Type	Receives
Intervention Group A	Experimental	Device: Pulsatile Flushing Technique (0.4s pause interval)Use of pulsatile flushing technique (0.4s pause interval)
Intervention Group B	Experimental	Other: Pulsatile Flushing Technique (1s pause interval)Use of pulsatile flushing technique (1s pause interval)
Control Group	Active comparator	Device: Bolus Flushing TechniqueStandard bolus flushing technique

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulsatile Flushing Technique (0.4s pause interval)Also: Catheter Care Simulation SystemPulsatile 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).	Device	Intervention Group A
Pulsatile Flushing Technique (1s pause interval)Also: Catheter Care Simulation SystemPulsatile 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).	Other	Intervention Group B
Bolus Flushing TechniqueBolus flushing technique involves the continuous administration of a single, concentrated volume of flush solution resulting in consistent laminar flow	Device	Control Group

Primary outcome

Time-to-event T-CVAD Blockage
Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
BackgroundChan, 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: PubMed 21748725Guiffant 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.
BackgroundJ. Mehta, H. (2021). Hemodialysis Vascular Access with Central Venous Disease. IntechOpen. doi: 10.5772/intechopen.9303
Background: PubMed 30589719Boord C. Pulsatile Flushing: A Review of the Literature. J Infus Nurs. 2019 Jan/Feb;42(1):37-43. doi: 10.1097/NAN.0000000000000311.
Background: PubMed 38477478Giraudeau 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.
BackgroundWorld Health Organization. (n.d.). Cluster Randomized Trials 4.3. In WHO Guidance on Research Methods for Health-EDRM (pp. 266-270).
Background: PubMed 8912825Geller 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.
Background: PubMed 26322512Wolf 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.
BackgroundPatel, 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.
BackgroundLee, 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.
BackgroundCDC. (2020). Guidelines for the Prevention and Treatment of Catheter-Related Bloodstream Infections. Centers for Disease Control and Prevention.
Background: PubMed 32778223Lok 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

SUNG Ka Ming Dorothy, KCC NC (Renal Care) contact

852-3506 ext. 6507

bskmd01@ha.org.hk

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SUNG Ka Ming Dorothy, KCC NC (Renal Care) (852-3506 ext. 6507, bskmd01@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-event T-CVAD Blockage (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567456, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.