REPLACE: The Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection

Официальное название

REPLACE: the Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection

Обзор

With this project the investigators aim to address the following question: "Is it beneficial to change bladder catheters during urinary tract infections?" There is debate regarding the usefulness of changing an indwelling catheter during antibiotic treatment of a catheter-associated urinary tract infection (CAUTI). The current guideline recommends catheter replacement, but is based on limited evidence. Our hypothesis is that there is no added value for patients to change the catheter during an antibiotic treatment for CAUTI. If refraining from catheter replacement is non inferior, this would result in a reduction of invasive procedures and reduction of healthcare associated costs. Patients with CAUTI and an indication for antibiotic treatment will be randomized to catheter replacement or no catheter replacement. The study will be conducted in academic and non-academic hospitals in The Netherlands. 300 patients will need to be included.

Подробное описание

As a result of the widespread application of urinary catheterization, catheter-associated urinary tract infection (CAUTI) is the most common healthcare associated infection. To fasten recovery and reduce the risk of a recurrent CAUTI, current guidelines recommend to replace the catheter at the onset of a CAUTI when the indwelling catheter has been in place for more than 2 weeks. This recommendation, however, is based on limited evidence. Additionally, there is significant practice variation in the Netherlands regarding catheter replacement in CAUTI. Given the limited evidence and significant practice variation in the Netherlands, this Randomized Controlled Trial including 300 CAUTI patients is needed.

The main question this study aims to answer is whether not changing the urinary catheter (catheter retainment) during a catheter-associated urinary tract infection (CAUTI) is non-inferior to catheter replacement in terms of the risk of a recurrent CAUTI within 90 days. Secondary objectives include 30-day mortality, health-related quality of life, time to resolution of CAUTI symptoms, complications of catheter replacement (e.g., discomfort, bleeding, sepsis) and healthcare and societal costs.

In the intervention group there will be no catheter replacement during CAUTI, meaning there will be no catheter replacement during the entire course of antibiotic treatment. In this group, catheter replacement will follow the patients regular replacement schedule, consequently meaning that it occurs outside the duration of the antibiotic treatment . The duration of antibiotic treatment is 10 days for both men and women. The control group follows the current guidelines. In this group, the catheter will be replaced within 3 days after the start of antibiotic therapy.

Вмешательства

• Процедура Catheter replacement
  In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results.
• Процедура Catheter retainment
  In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule. The control group undergoes catheter replacement within 3 days of starting antibiotic therapy. Choice of antibiotic agent follows standard care guidelines, with adjustments based on culture results.

Первичные конечные точки

• Recurrent CAUTI within 90 days post-antibiotic treatment (T0 is the start of antibiotic treatment) [Срок оценки: 90 days]

Вторичные конечные точки (8)

• Mortality [Срок оценки: 180 days]
• Health-related quality of life measured using the PROMIS questionnaires [Срок оценки: 90 days]
• Health-related quality of life measured using the EQ-5D-5L questionnaire [Срок оценки: 180 days]
• Time to resolution of CAUTI symptoms [Срок оценки: 90 days]
• Complications of catheter replacement [Срок оценки: 3 days]
• Healthcare costs using a selection of items relevant for this population of the medical consumption (iMCQ) questionnaire [Срок оценки: 90 days and 180 days]
• Societal costs using a selection of items relevant for this population of the productivity (iPCQ) questionnaire [Срок оценки: 90 days and 180 days]
• Length of hospital stay and ICU-admission during hospital stay [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Aged 18 years or older.
• An indwelling catheter, either a transurethral or suprapubic catheter, that has been in place for at least 2 weeks.
• At least one CAUTI-related symptom, defined according to the IDSA guideline (11): onset or worsening of fever (> 38 degrees), rigors, altered mental status, malaise or lethargy with no other identified cause, flank pain, costovertebral angle tenderness, acute haematuria, pelvic discomfort, or suprapubic pain/tenderness. In patients with spinal cord injury, increased spasticity, autonomic dysreflexia, or sense of unease are also compatible with CAUTI.
• Urine culture with ≥ 103 colony-forming units (CFU)/mL of ≥ 1 bacterial species, or urine culture with <103 CFU/mL along with a positive blood culture with the same microorganism as the urine culture.
• The ability to provide written informed consent for the use of their data.
• Sufficient proficiency in the Dutch or English language, both spoken and written, to effectively communicate with the research team and accurately complete the questionnaires.

Критерии исключения

• Having an immunodeficiency: High-dose corticosteroid use (any equivalent of ≥ 20 mg prednisolone per day for > 4 weeks), severe primary immunodeficiency, organ transplant, neutropenia (absolute neutrophil count < 0.50 x 10⁹/L)
• Expiration of the indication of the indwelling catheter.
• Having a planned (routine) catheter replacement during antibiotic therapy.
• Contraindications for catheter replacement (judgement treating physician)
• Kidney catheters (nephrostomy or double-J catheter).
• Needing bladder irrigations because of gross haematuria.
• Having bladder stones.
• Female patients who are pregnant.
• Having a life expectancy of < 3 months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Leiden University Medical Center — Leiden

Публикации

• Schippers E, van Uhm J, Wilmsen M, Tigchelaar A, Rozemeijer W, Schout B, van den Akker-van Marle E, van der Beek M, Kummeling M, Groenwold R, Geerlings S, Lambregts M; REPLACE study group. The impact of catheter replacement in patients with catheter-associated urinary tract infection: study protocol paper for a multicentre, non-inferiority randomized controlled trial (REPLACE). BMC Infect Dis. 202 PMID 41761084

Идентификаторы

NCT: NCT06936631 · NL88486.058.25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗