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NCT Number: NCT07567456

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

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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Key information

Conditions

Haemodialysis Patients Blockage of Tunnelled Central Venous Access Device Pulsatile Flushing Technique

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital

Kowloon, Hong Kong

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Catheter Care Simulation System

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).

Other names: Catheter Care Simulation System

Bolus Flushing Technique

Device

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

Primary outcomes

  1. 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.

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Sponsors and collaborators

Lead sponsor

Queen Elizabeth Hospital, Hong Kong

Other

Collaborators

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

Registry information

Official study 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

Acronym: Non-RCT HD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 5, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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