REPLACE: the Impact of Catheter Replacement in Patients With Catheter-associated Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrent CAUTI within 90 days post-antibiotic treatment (T0 is the start of antibiotic treatment)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Catheter replacement
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.
干预措施: Catheter replacement (Procedure)
Catheter retainment
In the intervention group, the catheter is not replaced during CAUTI treatment. Choice of antibiotic agent follows standard careguidelines, with adjustments based on culture results. In this group, catheter replacement occurs according to the patient's regular schedule.
干预措施: Catheter retainment (Procedure)
结局指标
主要结局
Recurrent CAUTI within 90 days post-antibiotic treatment (T0 is the start of antibiotic treatment)
时间窗: 90 days
The definition of a recurrent CAUTI is identical to the definition used for inclusion. The pathogen does not have to be identical to the causative pathogen that was identified during the first episode. In case of a suspected recurrence, the following data will be collected: signs and symptoms, GCS, qSOFA, laboratory results, admission, antimicrobial treatment and treatment duration.
次要结局
- Mortality(180 days)
- Health-related quality of life measured using the PROMIS questionnaires(90 days)
- Complications of catheter replacement(3 days)
- Healthcare costs using a selection of items relevant for this population of the medical consumption (iMCQ) questionnaire(90 days and 180 days)
- Health-related quality of life measured using the EQ-5D-5L questionnaire(180 days)
- Time to resolution of CAUTI symptoms(90 days)
- Societal costs using a selection of items relevant for this population of the productivity (iPCQ) questionnaire(90 days and 180 days)
- Length of hospital stay and ICU-admission during hospital stay(90 days)
研究者
ecschippers
Coordinating investigator/ project leader
Leiden University Medical Center