Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01570556
First received: March 15, 2012
Last updated: April 3, 2012
Last verified: March 2012

March 15, 2012
April 3, 2012
December 2011
December 2013   (final data collection date for primary outcome measure)
Change in serum inflammatory markers (CRP, IL-6) [ Time Frame: 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01570556 on ClinicalTrials.gov Archive Site
Cardio-vascular events [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Inflammation on Dialysis
  • Bacteriuria in Hemodialysis Patients
Other: Antibiotic treatment
In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.
  • 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.
    Intervention: Other: Antibiotic treatment
  • No Intervention: Patients with positive culture, observation only
    These asymptomatic patients with positive urine culture, will be observed only during the study period.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Not Provided
Israel
 
NCT01570556
193/11
Not Provided
Assaf-Harofeh Medical Center
Assaf-Harofeh Medical Center
Not Provided
Not Provided
Assaf-Harofeh Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP