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

Queen Elizabeth Hospital, Hong Kong591 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

591

Conditions

Haemodialysis Patients Blockage of Tunnelled Central Venous Access Device

Interventions

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

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 TechniqueDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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.

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.