Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
Recruitment status was Recruiting
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.
Inflammation on Dialysis
Bacteriuria in Hemodialysis Patients
Other: Antibiotic treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients|
- Change in serum inflammatory markers (CRP, IL-6) [ Time Frame: 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
- Cardio-vascular events [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Patients with positive culture, treatment group
These asymptomatic patients with positive urinary culture, seven days of antibiotics will be given according to the bacteriogram sensitivity.
Other: Antibiotic treatment
In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.
No Intervention: Patients with positive culture, observation only
These asymptomatic patients with positive urine culture, will be observed only during the study period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570556
|Nephrology Department, Assaf Harofeh Medical Center||Recruiting|
|Zerifin, Israel, 70300|
|Contact: Ilia Beberashvili, MD 972577346133 firstname.lastname@example.org|
|Contact: Kobi Stav, MD 972527493007 email@example.com|
|Principal Investigator: Ilia Beberashvili, MD|