Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients

Phase 4

• Conditions: Inflammation on Dialysis; Bacteriuria in Hemodialysis Patients
• Interventions: Other: Antibiotic treatment

• Registration Number: NCT01570556
• Lead Sponsor: Assaf-Harofeh Medical Center

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 available

Study Timeline

• Study Start: 2011-12
• Status Verified: 2012-03
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-04-03
• Last Update Submitted: 2012-04-03
• Study First Posted: 2012-04-04
• Last Update Posted: 2012-04-04
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with positive culture, treatment group	Antibiotic treatment	These asymptomatic patients with positive urinary culture, seven days of antibiotics will be given according to the bacteriogram sensitivity.

Primary Outcome Measures

Name	Time	Method
Change in serum inflammatory markers (CRP, IL-6)	3 months, 6 months, and 12 months

Secondary Outcome Measures

Name	Time	Method
Cardio-vascular events	3 months, 6 months and 12 months

Trial Locations

Locations (1)

Nephrology Department, Assaf Harofeh Medical Center; 🇮🇱 Zerifin, Israel