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Предстои набиране Не е приложимо NCT07019610

Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial

Не е приложима фаза (напр. обсервационно)
Заболявания: Vascular Access Complication Device Related Infection Device Related Sepsis Catheter Infection Catheter Complications Catheter-Related Infections Catheter Related Complications Hemodialysis Catheter Infection Hemodialysis Catheter-associated Infection Hemodialysis Complication

Спонсор: The University of Queensland

Налично на: БГ
Обобщение
The goal of this clinical trial is to compare a chlorhexidine antimicrobial barrier cap in patients requiring hemodialysis treatment to the standard hemodialysis caps currently used within the Metro North Kidney Health Service. The main questions to answer are: * Study Feasibility * Occurrence of infectious complications related to renal central venous catheters Participants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub: * The standard hemodialysis cap used at the Royal Brisbane and Women's Hospital, or * The intervention hemodialysis cap containing chlorhexidine inside it Researchers will compare standard and chlorhexidine hemodialysis caps to see if the presence of chlorhexidine improves the occurrance of infectious complications related to the hemodialysis catheter.
Описание
This study is a single-centre, two-arm, parallel group Randomized Controlled Trial (RCT) to test the effectiveness, safety, impact of device application on health-related quality of life measures, and cost-effectiveness of ClearGuard™ HD antimicrobial barrier caps in patients receiving hemodialysis. Setting and Sample: The ECHO-HD will be undertaken at the Metro North Kidney Health Service (MNKHS), Royal Brisbane and Women's Hospital in Queensland, Australia. Sample Size: The investigators will recruit 60 patients with 30 patients per arm. The purpose of the pilot study is to assess research project feasibility and inform the design of a large scale powered RCT. Viechtbauer et al. (2015) determined that a sample size of 59 participants is sufficient to detect a problem with a 5% probability of occurrence.
Кой може да участва
Inclusion Criteria: * Age≥18 * Able to provide informed consent * Kidney failure requiring a tunnelled CVC for treatment (haemodialysis) * 21 days BSI free * No known allergy to chlorhexidine and/or nylon and/or polypropylene. Exclusion Criteria: * Current CLABSI * Known allergic to chlorhexidine and/or nylon and/or polypropylene. * Patients on an end-of-life pathway * People with a cognitive impairment and/or intellectual disability
Места на провеждане 1
Австралия (1)
Royal Brisbane and Women's Hospital
Herston , Queensland
Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.03.2026
Крайна дата
01.02.2028
Регистрационен номер
NCT07019610
Източник
anzctr
Запитване за медицински туризъм

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