Pulsatile Flushing Technique in Reducing Blockage of T-CVAD for Haemodialysis Patients (Non-RCT HD)

May 5, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

591

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: SUNG Ka Ming Dorothy, KCC NC (Renal Care)
  • Phone Number: 6507 852-3506
  • Email: bskmd01@ha.org.hk

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Recruiting
        • Queen Elizabeth Hospital
        • Contact:
          • Ka Ming Dorothy SUNG, KCC NC (Renal Care)
          • Phone Number: 6507 852-3506
          • Email: bskmd01@ha.org.hk
        • Principal Investigator:
          • Ka Ming Dorothy SUNG, KCC NC (Renal Care)
        • Sub-Investigator:
          • Kai Cheong Harris LAM, HOCS M(N)/ CNO
        • Sub-Investigator:
          • Suet Lai TAM, KWH NC (Renal Care)
        • Sub-Investigator:
          • Ngar Yee CHOW, NTEC NC (Renal Care)
        • Sub-Investigator:
          • Hau Sim Eva HO, HKEC NC (Renal Care)
        • Sub-Investigator:
          • May Ki LAM, QMH NC (Renal Care)
        • Sub-Investigator:
          • Lai Nga PO, NTWC NC (Renal Care)
        • Sub-Investigator:
          • Shuk Hang LEE, KWC & PMH NC (Renal Care)
        • Sub-Investigator:
          • Har Ping CHEUNG, TKOH APN (MED)
        • Sub-Investigator:
          • Victor CHEUNG, QEH EOII (MDSSC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group A
Use of pulsatile flushing technique (0.4s pause interval)
Device: 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).
Other Names:
  • Catheter Care Simulation System
Experimental: Intervention Group B
Use of pulsatile flushing technique (1s pause interval)
Other: 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).
Other Names:
  • Catheter Care Simulation System
Active Comparator: Control Group
Standard bolus flushing technique
Device: Bolus Flushing Technique
Bolus flushing technique involves the continuous administration of a single, concentrated volume of flush solution resulting in consistent laminar flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Elizabeth Hospital, Hong Kong

Collaborators

Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
Tung Wah Hospital
Tuen Mun Hospital
Kwong Wah Hospital
Pamela Youde Nethersole Eastern Hospital
Princess Margaret Hospital, Hong Kong
Caritas Medical Centre, Hong Kong
North District Hospital, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tseung Kwan O Hospital, Hong Kong
Yan Chai Hospital
Tin Shui Wai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIRB-2025-277-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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