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Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01570556
Enrollment
120
Registered
2012-04-04
Start date
2011-12-31
Completion date
Unknown
Last updated
2012-04-04

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

Conditions

Inflammation on Dialysis, Bacteriuria in Hemodialysis Patients

Keywords

Hemodialysis, Inflammation, Bacteriuria, Interleukin 6, C reactive protein

Brief summary

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.

Interventions

In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male or female, age \> 18 years, in chronic hemodialysis treatment at least 3 months 2. 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 3. Patients with native A-V Fistula or graft 4. Informed consent obtained before any trial-related activities

Exclusion criteria

1. Patients with an indwelling catheters 2. Patients with periodontitis 3. Patients with diabetic foot 4. Patients with active malignant disease or liver cirrhosis 5. Patients on chronic treatment with steroids on doses \> 10 mg/day Prednisone (or equivalent) 6. Patients treated with immunosuppressive agents 7. Patients suffering from * Acute vasculitis * Severe systemic infections * Heart failure (NYHA class III-IV)

Design outcomes

Primary

MeasureTime frame
Change in serum inflammatory markers (CRP, IL-6)3 months, 6 months, and 12 months

Secondary

MeasureTime frame
Cardio-vascular events3 months, 6 months and 12 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026