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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
591

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Elizabeth Hospital, Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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