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Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

This study is currently recruiting participants.
Verified March 2012 by Assaf-Harofeh Medical Center
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Inflammation on Dialysis
Bacteriuria in Hemodialysis Patients
 Other: Antibiotic treatment
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Change in serum inflammatory markers (CRP, IL-6) [ Time Frame: 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardio-vascular events [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570556

Locations
Israel
Nephrology Department, Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Ilia Beberashvili, MD     972577346133     iliab@asaf.health.gov.il    
Contact: Kobi Stav, MD     972527493007     stavkobi@gmail.com    
Principal Investigator: Ilia Beberashvili, MD            
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

Publications:

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01570556     History of Changes
Other Study ID Numbers: 193/11
Study First Received: March 15, 2012
Last Updated: April 3, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
Hemodialysis
Inflammation
Bacteriuria
Interleukin 6
C reactive protein

Additional relevant MeSH terms:
Bacteriuria
Inflammation
Urinary Tract Infections
Infection
Urologic Diseases
 Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013