Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
Primary Purpose
Inflammation on Dialysis, Bacteriuria in Hemodialysis Patients
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Antibiotic treatment
Sponsored by
About this trial
This is an interventional prevention trial for Inflammation on Dialysis focused on measuring Hemodialysis, Inflammation, Bacteriuria, Interleukin 6, C reactive protein
Eligibility Criteria
Inclusion Criteria:
- Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months
- 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
- Patients with native A-V Fistula or graft
- Informed consent obtained before any trial-related activities
Exclusion Criteria:
- Patients with an indwelling catheters
- Patients with periodontitis
- Patients with diabetic foot
- Patients with active malignant disease or liver cirrhosis
- Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent)
- Patients treated with immunosuppressive agents
Patients suffering from
- Acute vasculitis
- Severe systemic infections
- Heart failure (NYHA class III-IV)
Sites / Locations
- Nephrology Department, Assaf Harofeh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Patients with positive culture, treatment group
Patients with positive culture, observation only
Arm Description
These asymptomatic patients with positive urinary culture, seven days of antibiotics will be given according to the bacteriogram sensitivity.
These asymptomatic patients with positive urine culture, will be observed only during the study period.
Outcomes
Primary Outcome Measures
Change in serum inflammatory markers (CRP, IL-6)
Secondary Outcome Measures
Cardio-vascular events
Full Information
NCT ID
NCT01570556
First Posted
March 15, 2012
Last Updated
April 3, 2012
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01570556
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation on Dialysis, Bacteriuria in Hemodialysis Patients
Keywords
Hemodialysis, Inflammation, Bacteriuria, Interleukin 6, C reactive protein
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with positive culture, treatment group
Arm Type
Active Comparator
Arm Description
These asymptomatic patients with positive urinary culture, seven days of antibiotics will be given according to the bacteriogram sensitivity.
Arm Title
Patients with positive culture, observation only
Arm Type
No Intervention
Arm Description
These asymptomatic patients with positive urine culture, will be observed only during the study period.
Intervention Type
Other
Intervention Name(s)
Antibiotic treatment
Intervention Description
In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.
Primary Outcome Measure Information:
Title
Change in serum inflammatory markers (CRP, IL-6)
Time Frame
3 months, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Cardio-vascular events
Time Frame
3 months, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months
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
Patients with native A-V Fistula or graft
Informed consent obtained before any trial-related activities
Exclusion Criteria:
Patients with an indwelling catheters
Patients with periodontitis
Patients with diabetic foot
Patients with active malignant disease or liver cirrhosis
Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent)
Patients treated with immunosuppressive agents
Patients suffering from
Acute vasculitis
Severe systemic infections
Heart failure (NYHA class III-IV)
Facility Information:
Facility Name
Nephrology Department, Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilia Beberashvili, MD
Phone
972577346133
Email
iliab@asaf.health.gov.il
First Name & Middle Initial & Last Name & Degree
Kobi Stav, MD
Phone
972527493007
Email
stavkobi@gmail.com
First Name & Middle Initial & Last Name & Degree
Ilia Beberashvili, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
21852667
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.
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Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
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