NCT01612182

Brief Summary

The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
Last Updated

June 5, 2012

Status Verified

June 1, 2012

First QC Date

May 29, 2012

Last Update Submit

June 4, 2012

Conditions

End-stage Renal Disease

Keywords

end-stage renal diseaserenal replacement therapy

Outcome Measures

Primary Outcomes (1)

  • 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)

    During hospitalization

Secondary Outcomes (1)

  • The prevalence of ESBL Klebsiella pneumonia in patient with pneumonia and renal replacement therapy

    during hospitalization

Study Arms (2)

ESBL(+) Klebsiella pneumonia

All the patient who's the culture result showed ESBL(+) Klebsiella pneumonia in any site during hospitalization

Other: renal replacement therapy

ESBL(-) Klebsiella pneumonia

All the patient who's the culture result showed ESBL(-) Klebsiella pneumonia in any site during hospitalization

Other: renal replacement therapy

Interventions

renal replacement therapyOTHER

renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )

ESBL(+) Klebsiella pneumoniaESBL(-) Klebsiella pneumonia

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients had admitted in single center

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Seoul Paik hospital Instituional Board Review

Seoul, Je Dong 2ga, Jung Gu, 100-032, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nephrology division, Department of Internal Medicine

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 5, 2012

Study Start

March 1, 2012

Study Completion

May 1, 2012

Last Updated

June 5, 2012

Record last verified: 2012-06

Locations

KR(1)