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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQueen Elizabeth Hospital, Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Pulsatile Flushing Technique (1s pause interval)

    Other intervention

    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 Technique

    Device

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

Treatment groups

591 Participants
are divided into 3 treatment groups
Group A: Intervention Group AExperimental treatment 1 intervention
Group B: Intervention Group BExperimental treatment 1 intervention
Group C: Control GroupActive comparator 1 intervention

Trial outcomes

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Queen Elizabeth Hospital, Hong Kong

Lead sponsor

Kwong Wah Hospital

Collaborator

Prince of Wales Hospital, Shatin, Hong Kong

Collaborator

Alice Ho Miu Ling Nethersole Hospital

Collaborator

North District Hospital, Hong Kong

Collaborator

Caritas Medical Centre, Hong Kong

Collaborator

Queen Mary Hospital, Hong Kong

Collaborator

Tseung Kwan O Hospital, Hong Kong

Collaborator

Tin Shui Wai Hospital

Collaborator

Yan Chai Hospital

Collaborator

Tung Wah Hospital

Collaborator

Pamela Youde Nethersole Eastern Hospital

Collaborator

Tuen Mun Hospital

Collaborator

Princess Margaret Hospital, Hong Kong

Collaborator