End-stage Renal DiseaseNCT01612182
The Incidence of Extended-spectrum β-lactamase (ESBL) Klebsiella Pneumonia in Patient on Renal Replacement Therapy
An observational study of End-stage Renal Disease, run by Inje University at 1 site in South Korea.
Trial summary
The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- renal replacement therapy
- How many people
- 1,289 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to May 2012
- Phase
- Observational
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients had admitted in single center
Who may be able to join
- The age of patient was between 18 yrs and 79 yrs.
- The patient who showed Klebsiella pneumonia in 1st culture result of any site during hospitalization
Who cannot join
- The level of serum albumin was below 2.0 or over 5.0
- The level of AST or ALT was 2 times of normal level or the level of bilirubin was over 2.0 mg/dL during 1month.
- The level of Body mass index was below 15 or over 30
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inje University Seoul Paik hospital Instituional Board Review
Seoul, Je Dong 2ga, Jung Gu, 100-032
About this study
The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement therapy.
- Conditions
- End-stage Renal Disease
- Being tested
- renal replacement therapy
- Keywords
- end-stage renal disease, renal replacement therapy
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal replacement therapyOther
renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )
| Study group | Role | What they receive |
|---|---|---|
| ESBL(+) Klebsiella pneumonia | All the patient who's the culture result showed ESBL(+) Klebsiella pneumonia in any site during hospitalization Receives: Other: renal replacement therapy | |
| ESBL(-) Klebsiella pneumonia | All the patient who's the culture result showed ESBL(-) Klebsiella pneumonia in any site during hospitalization Receives: Other: renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy
The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy during hospitalization up to 8 years (from 2004 to 2011)
Measured: During hospitalization
Secondary outcomes (1)
The prevalence of ESBL Klebsiella pneumonia in patient with pneumonia and renal replacement therapy
The prevalence of ESBL Klebsiella pneumoina in patient with pneumonia and renal replacement therapy during hospitalization up to 8 years (from 2004 to 2011)
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1,289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoseok Koo, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612182
- Sponsor's protocol ID
- ESBL 2012-1
- Status last verified
- Jun 2012
- First submitted
- 29 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Extended-spectrum β-lactamase (ESBL) Klebsiella Pneumonia in Patient on Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT01612182
- Acronym / sponsor ID
- ESBL 2012-1
- Conditions
- End-stage Renal Disease
- Keywords
- end-stage renal disease, renal replacement therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,289 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Study completion
- May 2012 (actual)
- First posted
- 5 Jun 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.
The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement therapy.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESBL(+) Klebsiella pneumonia | – | Other: renal replacement therapyAll the patient who's the culture result showed ESBL(+) Klebsiella pneumonia in any site during hospitalization |
| ESBL(-) Klebsiella pneumonia | – | Other: renal replacement therapyAll the patient who's the culture result showed ESBL(-) Klebsiella pneumonia in any site during hospitalization |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients had admitted in single center
Key inclusion criteria (2 listed)
- The age of patient was between 18 yrs and 79 yrs.
- The patient who showed Klebsiella pneumonia in 1st culture result of any site during hospitalization
Key exclusion criteria (4 listed)
- The level of serum albumin was below 2.0 or over 5.0
- The level of AST or ALT was 2 times of normal level or the level of bilirubin was over 2.0 mg/dL during 1month.
- The level of Body mass index was below 15 or over 30
- Pregnancy
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 |
|---|---|---|
| renal replacement therapyrenal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy ) | Other | ESBL(+) Klebsiella pneumonia, ESBL(-) Klebsiella pneumonia |
Primary outcome
The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy
Time frame: During hospitalization
The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy during hospitalization up to 8 years (from 2004 to 2011)
1 secondary outcome
The prevalence of ESBL Klebsiella pneumonia in patient with pneumonia and renal replacement therapy
Time frame: during hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Inje University at 1 site in South Korea.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jun 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy (time frame: During hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2012.