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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000034437
Receipt No. R000039267
Scientific Title Topical mupirocin or gentamicin cream at the exit site for prevention of peritoneal dialysis catheter-related infections and withdrawal from peritoneal dialysis.
Date of disclosure of the study information 2018/10/15
Last modified on 2018/10/10

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Basic information
Public title Topical mupirocin or gentamicin cream at the exit site for prevention of peritoneal dialysis catheter-related infections and withdrawal from peritoneal dialysis.
Acronym Topical antibiotics cream at the exit site of peritoneal dialysis patients.
Scientific Title Topical mupirocin or gentamicin cream at the exit site for prevention of peritoneal dialysis catheter-related infections and withdrawal from peritoneal dialysis.
Scientific Title:Acronym Topical antibiotics cream at the exit site of peritoneal dialysis patients.
Region
Japan

Condition
Condition End-stage renal disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Topical antibiotics cream at the exit site for prevention of peritoneal dialysis catheter-related infections
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Peritonitis

Key secondary outcomes Exit site infection
Technical failure
Adverse event

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Peritoneal dialysis patients
Key exclusion criteria Recent use of antibiotics
Under 18 years of age
active infection
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohiro Toda
Organization Kansai Electric Power Hospital
Division name Division of Nephrology
Zip code
Address 2-1-7,Fukushima.Fukushima-ku. Osaka.553-0003. Japan
TEL +81-6-6458-5821
Email natoda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohiro Toda
Organization Kansai Electric Power Hospital
Division name Division of Nephrology
Zip code
Address 2-1-7,Fukushima.Fukushima-ku. Osaka.553-0003. Japan
TEL +81-6-6458-5821
Homepage URL
Email natoda@kuhp.kyoto-u.ac.jp

Sponsor
Institute The Japanese Society of dialysis and therapy
Institute
Department

Funding Source
Organization The Japanese Society of dialysis and therapy
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a systematic review on whether application of mupirocin ointment to exit site is effective in preventing exit site infection, peritonitis, or technical failure among patients treated with peritoneal dialysis (PD). It was also examined whether the application of mupirocin ointment is superior to application of gentamycin ointment to exit site in preventing exit site infection, peritonitis, or technical failure. This review is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines

Management information
Registered date
2018 Year 10 Month 10 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039267

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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