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

Tracking Information
First Received Date ^ICMJE	March 15, 2012
Last Updated Date	April 3, 2012
Start Date ^ICMJE	December 2011
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 3, 2012)	Change in serum inflammatory markers (CRP, IL-6) [ Time Frame: 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01570556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 3, 2012)	Cardio-vascular events [ Time Frame: 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
Official Title ^ICMJE	Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Inflammation on Dialysis Bacteriuria in Hemodialysis Patients
Intervention ^ICMJE	Other: Antibiotic treatment In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.
Study Arm (s)	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.
Publications *	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. Epub 2011 Aug 18.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	120
Completion Date	Not Provided
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01570556
Other Study ID Numbers ^ICMJE	193/11
Has Data Monitoring Committee	Not Provided
Responsible Party	Assaf-Harofeh Medical Center
Study Sponsor ^ICMJE	Assaf-Harofeh Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Assaf-Harofeh Medical Center
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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