Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

NCT ID: NCT01570556

Last Updated: 2012-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

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.

Conditions

Inflammation on Dialysis; Bacteriuria in Hemodialysis Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Antibiotic treatment

Intervention Type: OTHER

In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.

Patients with positive culture, observation only

These asymptomatic patients with positive urine culture, will be observed only during the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Antibiotic treatment

In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nephrology Department, Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Ilia Beberashvili, MD

Role: primary

iliab@asaf.health.gov.il

972577346133

Kobi Stav, MD

Role: backup

stavkobi@gmail.com

972527493007

References

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.

Reference Type: BACKGROUND

PMID: 21852667 (View on PubMed)

Other Identifiers

193/11

Identifier Type: -

Identifier Source: org_study_id