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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Pulsatile Flushing Technique (0.4s pause interval)
DevicePulsatile 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 interventionPulsatile 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
DeviceBolus flushing technique involves the continuous administration of a single, concentrated volume of flush solution resulting in consistent laminar flow
Treatment groups
Trial outcomes
Primary outcomes
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.
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