Идёт набор NCT07183592

Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the ICU - A Randomized Controlled Trial

Без фазы С лечением Intensive Care (ICU) Central Venous Catheter Related Infections Critical Care Nursing Catheter-associated Bloodstream Infections (CLABSI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 7-day Infusion set replacement, 4-day infusion set replacement.
Кому может быть актуально: Состояния в реестре: Intensive Care (ICU), Central Venous Catheter Related Infections, Critical Care Nursing, Catheter-associated Bloodstream Infections (CLABSI). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Impact of Infusion Line Change Frequency on Infectious Complications Related to Central Venous Catheters in the Intensive Care Unit ICU

Обзор

In the intensive care unit, patients' care and secure drugs administration require a central venous catheter. These invasive devices can lead to complications, particularly infections. Most preventive recommendations focus on catheter insertion, line handling, and dressings. Few recommendations adress catheter dwell time, which is certainly the main source of infection. Part of the prevention strategy is the regular and systematic replacement of infusion sets , as they may become contaminated during use, mainly through the hands of healthcare professionals. Prolonged use increases the risk of infection. Infusion lines changes involve disconnecting the old sets, discarding infusion devices containing drug residues, and replacing them with new sterile devices. Current international guidelines recommend replacing these sets every 4 days, and the Center for Disease Control and Prevention recommends not exceeding 7 days. Replacing these devices requires the time of qualified nurses, numerous sterile medical devices, and medications. In addition to the intended effect on infection prevention, the procedure has impacts on workload and costs. The objective of the study is to demonstrate that changing infusion set every 7 days does not increase the rate of central venous catheters related infections compared with changing infusion set every 4 days.

Вмешательства

Процедура 7-day Infusion set replacement
7-day infusion set replacement (Experimental arm) In this group, the infusion sets (the tubes and connectors used to deliver medications through the central venous catheter) will be changed once a week, every 7 days. During each replacement, all sets will be disconnected and replaced with new sterile ones.
Процедура 4-day infusion set replacement
4-day infusion set replacement (Active comparator arm) In this group, the infusion sets will be changed every 4 days, which reflects the most common international recommendation. The procedure is the same: all sets connected to the central venous catheter will be replaced with new sterile ones. This strategy represents the current standard of care and will serve as the comparison for the 7-day approach.

Первичные конечные точки

Rate (%) of patients with with a central venous catheter-related infectious complication [Срок оценки: From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).]

Вторичные конечные точки (8)

Central line-associated bloodstream infection (CLABSI) [Срок оценки: Day 90]
Non-central line-associated bloodstream infection [Срок оценки: Day 90]
Catheters with catheter colonization [Срок оценки: From central venous catheter insertion until 48 hours after catheter removal during the ICU stay (censored at 90 days).]
Time to onset of central venous catheter-related infectious complication [Срок оценки: Day 90]
ICU length of stay [Срок оценки: Day 90]
All-cause ICU mortality [Срок оценки: Day 90]
Cumulative nursing time related to infusion set replacements [Срок оценки: 1000 days]
Cost of materials required for infusion set replacements [Срок оценки: 1000 days]

Критерии участия

Критерии включения

Adult patient
Any ICU patient with a central venous catheter (inserted by venipuncture) in place for less than 72 hours and with an expected dwell time of at least 7 days
Patient affiliated with or covered by a social security system
Patient who has given verbal consent or written consent from a third party or in the event that the patient is unable to give consent.

Критерии исключения

Patient with a documented bloodstream infection at the time of inclusion
Patient whose central venous catheter has been in place for more than 72 hours
Patient with suspected catheter-related infection
Patient whose study catheter was inserted using a guidewire exchange
Patient previously enrolled in the study during the same ICU stay
Patient whose condition, according to the clinician, does not allow safe placement of a central venous catheter, such as: