Bacteriuria in Hemodialysis Patients Clinical Trial
Official title:
Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
| NCT number | NCT01570556 |
| Other study ID # | 193/11 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 4 |
| First received | March 15, 2012 |
| Last updated | April 3, 2012 |
| Start date | December 2011 |
| Verified date | March 2012 |
| Source | Assaf-Harofeh Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Israel | Nephrology Department, Assaf Harofeh Medical Center | Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in serum inflammatory markers (CRP, IL-6) | 3 months, 6 months, and 12 months | No | |
| Secondary | Cardio-vascular events | 3 months, 6 months and 12 months | No |