The REPLACE study aims to determine whether not changing the catheter (catheter retained) for catheter-associated urinary tract infections (CAUTI)affects the recurrence-risk of CAUTI.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Urinary tract signs and symptoms
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: Recurrent CAUTI within 90 days post-antibiotic treatment.
Secondary outcome
Secondary outcomes include 30-day mortality, health-related quality of life
(PROMIS, EQ-5D-5L), time to resolution of CAUTI symptoms, complications of
catheter replacement (e.g., discomfort, bleeding, sepsis), length of hospital
stay, healthcare costs, and productivity.
Background summary
With this project we aim to address knowledge question no.3 of the Urology
knowledge agenda: "Is it beneficial to change bladder and kidney catheters
during urinary tract infections?" There is debate regarding the usefulness of
changing an indwelling catheter during antibiotic treatment of a
catheterassociated 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 noninferior, 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 distributed across the country.
Study objective
The REPLACE study aims to determine whether not changing the catheter (catheter
retained) for catheter-associated urinary tract infections (CAUTI)
affects the recurrence-risk of CAUTI.
Study design
This is a multicenter randomized controlled trial, utilizing a 1:1 allocation.
In total 300 participants.
Intervention
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.
Study burden and risks
Even though guidelines state that catheters should be replaced in patients with
CAUTI, there is significant practice variation in the Netherlands due to the
limited evidence. In practice, this means that both changing the catheter as
well as retainment is standard care.
Both treat-ments have potential risks and benefits: catheter retainment could
potentially result in pro-longed symptoms and an increased risk of recurrence,
while changing the catheter has risk of complications such as bleeding, fausse
route, bacteremia and bladder spasms.
Participating takes 6 months in total. Within these 6 months, each patient will
be phoned 8 times. Each consult takes approximally 10-15 minutes.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
In order to participate in the trial, a patient must meet all of the following
criteria:
1. Aged 18 years or older.
2. An indwelling catheter, either a transurethral or suprapubic catheter, that
has been in place for at least 2 weeks.
3. At least one CAUTI-related symptom, defined according to the IDSA guideline:
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.
4. 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.
5. The ability to provide written informed consent for the use of their data.
6. Sufficient proficiency in the Dutch or English language, both spoken and
written, to effectively communicate with the research team and accurately
complete the questionnaires.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in the trial:
1. Having an immunodeficiency: High-dose corticosteroid use (equivalent of >= 20
mg prednisolone per day for > 4 weeks), severe primary immunodeficiency, organ
transplant, neutropenia (absolute neutrophil count < 0.50 x 10*/L)
2. Expiration of the indication of the indwelling catheter.
3. Having a planned (routine) catheter replacement during antibiotic therapy.
4. Contraindications for catheter replacement (judgement treating physician)
5. Kidney catheters (nephrostomy or double-J catheter).
6. Needing bladder irrigations because of gross haematuria.
7. Having bladder stones.
8. Female patients who are pregnant.
9. Having a life expectancy of < 3 months.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88486.058.25 |