Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

April 3, 2012 updated by: Assaf-Harofeh Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Recruiting
        • Nephrology Department, Assaf Harofeh Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum inflammatory markers (CRP, IL-6)
Time Frame: 3 months, 6 months, and 12 months
3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardio-vascular events
Time Frame: 3 months, 6 months and 12 months
3 months, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 193/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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