Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

Study Overview
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Brief Summary
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When considering occult infections during the diagnostic workup of inflammation in Hemodialysis (HD) patients, the urine-deprived bladder is frequently dismissed as potential site of infection. The urinary tract, even in end stage renal disease (ESRD) patients on hemodialysis may represent a significant reservoir for infection. Delayed diagnosis is a relevant issue because the urinary tract is often overlooked as a source of infection in dialysis patients, especially because of absence of urinary tract infection (UTI) symptoms in HD patients. Contributing factors to asymptomatic UTI in HD patients include the presence of low urine volume, bladder stasis, and the fact that UTI symptoms are mostly related to voiding, which is reduced or absent in these patients. Persistence of asymptomatic bacteriuria and UTI may be related to higher levels of inflammatory markers in HD population. In view of the association between cardiovascular disease and cardio-vascular and all-cause mortality with inflammation, as expressed by elevated CRP and/or IL-6 levels in HD patients, the investigators questioned whether presence of asymptomatic UTI could contribute to elevated levels of inflammatory markers in patients with ESRD on maintenance HD therapy. Such a finding would provide a potential link between a treatable infection and a potential cardiovascular risk factor in this population.

Official Title
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Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

Conditions
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Inflammation on Dialysis, Bacteriuria in Hemodialysis Patients

Intervention / Treatment
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* Other: Antibiotic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and hemodialysis performed at least 3 times weekly Patients with native A-V Fistula or graft Informed consent obtained before any trial-related activities Exclusion Criteria: Patients with an indwelling catheters Patients with periodontitis Patients with diabetic foot Patients with active malignant disease or liver cirrhosis Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent) Patients treated with immunosuppressive agents Patients suffering from Acute vasculitis Severe systemic infections Heart failure (NYHA class III-IV)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with positive culture, treatment group<br>These asymptomatic patients with positive urinary culture, seven days of antibiotics will be given according to the bacteriogram sensitivity. | Other: Antibiotic treatment<br>* In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.<br>|
| No Intervention: Patients with positive culture, observation only<br>These asymptomatic patients with positive urine culture, will be observed only during the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum inflammatory markers (CRP, IL-6) |  | 3 months, 6 months, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio-vascular events |  | 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Inflammation, Bacteriuria, Interleukin 6, C reactive protein