Inflammation on DialysisPhase 4NCT01570556
Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
A Phase 4 study testing Antibiotic treatment in people with Inflammation on Dialysis and Bacteriuria in Hemodialysis Patients, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation on Dialysis, Bacteriuria in Hemodialysis Patients
- What is being tested?
- Antibiotic treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Patients suffering from
- Acute vasculitis
- Severe systemic infections
- Heart failure (NYHA class III-IV)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Nephrology Department, Assaf Harofeh Medical Center
Tsrifin, 70300
Ilia Beberashvili, MD, 972577346133, iliab@asaf.health.gov.il
Kobi Stav, MD, 972527493007, stavkobi@gmail.com
About this study
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.
- Being tested
- Antibiotic treatment
- Keywords
- Hemodialysis, Inflammation, Bacteriuria, Interleukin 6, C reactive protein
- Medical subject headings
- Inflammation, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic treatmentOther
In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Patients with positive culture, treatment group | Active comparator | These asymptomatic patients with positive urinary culture, seven days of antibiotics will be given according to the bacteriogram sensitivity. Receives: Other: Antibiotic treatment |
| Patients with positive culture, observation only | No intervention | These asymptomatic patients with positive urine culture, will be observed only during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum inflammatory markers (CRP, IL-6)
Measured: 3 months, 6 months, and 12 months
Secondary outcomes (1)
Cardio-vascular events
Measured: 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammation on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570556
- Sponsor's protocol ID
- 193/11
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 4 Apr 2012
- Results posted
- No
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. doi: 10.2215/CJN.01770211. Epub 2011 Aug 18.
PubMed 21852667
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Bacteriuria on Chronic Inflammation in Asymptomatic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01570556
- Acronym / sponsor ID
- 193/11
- Keywords
- Hemodialysis, Inflammation, Bacteriuria, Interleukin 6, C reactive protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with positive culture, treatment group | Active comparator | Other: Antibiotic treatmentThese asymptomatic patients with positive urinary culture, seven days of antibiotics will be given according to the bacteriogram sensitivity. |
| Patients with positive culture, observation only | No intervention | –These asymptomatic patients with positive urine culture, will be observed only during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic treatmentIn patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity. | Other | Patients with positive culture, treatment group |
Primary outcome
Change in serum inflammatory markers (CRP, IL-6)
Time frame: 3 months, 6 months, and 12 months
1 secondary outcome
Cardio-vascular events
Time frame: 3 months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2012.
- Background: PubMed 21852667Beberashvili 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nephrology Department, Assaf Harofeh Medical Center
Tsrifin, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic treatment in people with Inflammation on Dialysis and Bacteriuria in Hemodialysis Patients, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum inflammatory markers (CRP, IL-6) (time frame: 3 months, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2012.