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A randomized clinical trial comparing nitrofurazone-coated and uncoated urinary catheters in kidney transplant recipients

A randomized clinical trial comparing nitrofurazone-coated and uncoated urinary catheters in kidney transplant recipients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57888785
Enrollment
214
Registered
2018-05-30
Start date
2013-03-04
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary tract infections Urological and Genital Diseases Urinary tract infection, site not specified

Interventions

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, Ste

Sponsors

Hospital do Rim
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Incidence of discomfort, etiological agents and urinary sediment at baseline (transplant day), 7 days, 14 days and 30 days after kidney transplantation.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026