Clinical trial NCT01570556: Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
Official title: Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inflammation on Dialysis
Bacteriuria in Hemodialysis Patients
Keywords: Hemodialysis
Inflammation
Bacteriuria
Interleukin 6
C reactive protein
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in serum inflammatory markers (CRP, IL-6)
timeFrame: 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Cardio-vascular events
timeFrame: 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Nephrology Department, Assaf Harofeh Medical Center
Study officials:
References:
citation: Beberashvili I, Sinuani I, Azar A, Yasur H, Shapiro G, Feldman L, Averbukh Z, Weissgarten J. IL-6 levels, nutritional status, and mortality in prevalent hemodialysis patients. Clin J Am Soc Nephrol. 2011 Sep;6(9):2253-63. doi: 10.2215/CJN.01770211. Epub 2011 Aug 18.