A randomized clinical trial comparing nitrofurazone-coated and uncoated urinary catheters in kidney transplant recipients
| ISRCTN | ISRCTN57888785 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57888785 |
| Secondary identifying numbers | 0734/10 |
- Submission date
- 22/05/2018
- Registration date
- 30/05/2018
- Last edited
- 12/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Urinary tract infections are frequent complications early after kidney transplantation, and although simple infection control measures may be effective, the use of antimicrobial coated catheters in settings other than transplantation has shown promising results for infection prevention. The aim of this study is to compare the effectiveness of nitrofurazone-coated silicone urinary catheters with non-impregnated silicone urinary catheters at reducing bacteriuria (bacteria in urine) and urinary tract infections in kidney transplant recipients.
Who can participate?
Living donor kidney transplant recipients
What does the study involve?
Participants are randomly allocated to either a nitrofurazone-coated silicone urinary catheter or a non-impregnated silicone urinary catheter. The total duration of treatment was 7 days. Rates of bacteriuria, urinary infection and antimicrobial resistance are measured at the start of the study, and at 7, 14 and 30 days after kidney transplantation.
What are the possible benefits and risks of participating?
The possible benefits are the reduction of bacteriuria and urinary infection after kidney transplantation. The risks to the participants would be discomfort with the use of the bladder catheter, hematuria (blood in urine), and obstruction of the urinary flow.
Where is the study run from?
Hospital do Rim, São Paulo (Brazil)
When is the study starting and how long is it expected to run for?
June 2010 to December 2014
Who is funding the study?
CAPES Scholarship (Brazil)
Who is the main contact?
Dr Fernando Menezes
Contact information
Scientific
1048, Portugal Avenue
São Paulo
04559002
Brazil
Study information
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomized clinical trial comparing nitrofurazone-coated and uncoated urinary catheters in kidney transplant recipients |
| Study objectives | Urinary tract infections (UTI) are the most common bacterial infections in kidney transplant recipients, accounting for significant morbidity and increased costs. The incidence of UTI in kidney transplant recipients ranges from 7% to 43% and occur mainly during the first month after transplantation. Urinary tract infections and asymptomatic bacteriuria have been associated with impaired graft function, frequent, and sometimes unnecessary, antibiotic use and may precede pyelonephritis, with relevant clinical consequences. Thus, prevention of urinary tract infections and asymptomatic bacteriuria, mainly employing standard nosocomial infection prevention measures may have a significant impact after kidney transplantation. The purpose of this study was to compare the efficacy of Nitrofurazone-coated silicone urinary catheters with non-impregnated silicone urinary catheters in reducing bacteriuria and urinary tract infections in kidney transplant recipients. |
| Ethics approval(s) | Ethics and Research Committee of the Universidade Federal de São Paulo, 08/12/2010, ref: 0734/10 |
| Health condition(s) or problem(s) studied | Urinary tract infections |
| Intervention | Participants were randomized one day before kidney transplantation with a computer-generated system in a 1:1 ratio to a 3-way nitrofural-impregnated silicone catheter (StrataNF, Rochester Medical, Stewartville, Minnesota, USA) or a 3-way non-impregnated silicone catheter (Silmag, Silmag Brasil Produtos Médicos, Sorocaba, São Paulo, Brazil). The principal investigator, clinicians, nurses and participants were not masked to the allocated intervention because of the distinctive appearances of each catheter. All patients were maintained on a triple immunosuppressive regimen (usually tacrolimus, mycophenolic acid and prednisone), with or without induction (antithymocyte globulin). Acute rejection treatment consisted of intravenous corticosteroids bolus for three to five consecutive days, followed by a course of antithymocyte globulin in the case of corticoid resistance. Perioperative Cefazolin was used as surgical prophylaxis for 24 hours after transplantation, and trimethoprim/sulfamethoxazole (80 mg / 400 mg) was maintained daily for six months. The total duration of treatment was 7 days. The follow-up was 1 year after kidney transplantation. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Asymptomatic bacteriuria rates, urinary infection rates and antimicrobial resistance rates at baseline (transplant day), 7 days, 14 days and 30 days after kidney transplantation |
| Secondary outcome measures | Incidence of discomfort, etiological agents and urinary sediment at baseline (transplant day), 7 days, 14 days and 30 days after kidney transplantation. |
| Overall study start date | 01/06/2010 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 214 patients |
| Key inclusion criteria | Patients included were older than 18 years and consecutively undergoing urethral catheterization for kidney transplantation with a living donor from March 2013 to December 2014 |
| Key exclusion criteria | 1. Patients with asymptomatic bacteriuria or urinary tract infection at baseline 2. Deceased kidney transplant donors 3. Patients with known hypersensitivity to nitrofurantoin 4. Pregnancy 5. Those refusing to sign the informed consent form |
| Date of first enrolment | 04/03/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Brazil
Study participating centre
São Paulo
04038-002
Brazil
Sponsor information
Hospital/treatment centre
960 Borges Lagoa Street
São Paulo
04038002
Brazil
| Website | www.hrim.com.br |
|---|---|
"ROR" |
https://ror.org/045e9rc94 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The additional documents will be available. The protocol is not available online. Planned submission of the results to the American Journal of Infection Control in June 2018. |
| IPD sharing plan | The dataset will be held at the university (Universidade Federal de São Paulo). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2019 | Yes | No |
Editorial Notes
12/12/2018: Publication reference added.
