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

Study acronym: Non-RCT HD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Interventions: Bolus Flushing Technique (Other), Pulsatile Flushing Technique (0.4s pause interval) (Other), Pulsatile Flushing Technique (1s pause… to Bolus Flushing Technique (Device), Pulsatile Flushing Technique (0.4s pause interval) (Device), Pulsatile Flushing Technique (1s pause…
    • Study title shortened, about 3 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07567456
Lead Sponsor Queen Elizabeth Hospital, Hong Kong
Collaborators: Kwong Wah Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Alice Ho Miu Ling Nethersole Hospital, North District Hospital, Hong Kong, Caritas Medical Centre, Hong Kong, Queen Mary Hospital, Hong Kong, Tseung Kwan O Hospital, Hong Kong, Tin Shui Wai Hospital, Yan Chai Hospital, Tung Wah Hospital, Pamela Youde Nethersole Eastern Hospital, Tuen Mun Hospital, Princess Margaret Hospital, Hong Kong
Conditions
(from sponsor)		 Haemodialysis Patients, Blockage of Tunnelled Central Venous Access Device, Pulsatile Flushing Technique
Enrollment 591 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov