UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033557
Receipt No. R000038269
Scientific Title Prevalence and Appropriateness of Indwelling Urinary Catheters among Stroke Patients
Date of disclosure of the study information 2018/11/24
Last modified on 2019/08/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prevalence and Appropriateness of Indwelling Urinary Catheters among Stroke Patients
Acronym Prevalence and Appropriateness of Indwelling Urinary Catheters among Stroke Patients
Scientific Title Prevalence and Appropriateness of Indwelling Urinary Catheters among Stroke Patients
Scientific Title:Acronym Prevalence and Appropriateness of Indwelling Urinary Catheters among Stroke Patients
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurology Infectious disease Urology
Neurosurgery Emergency medicine Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To clarify the prevalence of indwelling urinary catheter, the proportion of appropriate urinary catheter utilization, and the incidence of catheter-related urinary tract infection (CAUTI) and urinary retention among stroke patients
2) To clarify the effect on the proportion of appropriate urinary catheter utilization and the incidence of CAUTI and urinary retention by education to medical staffs about urinary catheter management for prevention of CAUTI and the system for reminding withdrawal of inappropriate urinary catheters in stroke care
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of appropriate catheter utilization
Key secondary outcomes The proportion of catheter utilization
(The proportion of patients with urinary catheters, The number of days with urinary catheters)
The incidence rate of CAUTI
The incidence proportion of urinary retention

Base
Study type Observational

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Stroke patients (cerebral infarction, atraumatic intracerebral hemorrhage, atraumatic subarachnoid hemorrhage)
Key exclusion criteria Use of urinary catheterization, intermittent urinalysis, or urostomy prior to the onset of stroke
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Nakayama
Organization Kyoto University School of Public Health
Division name Health Informatics
Zip code
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
TEL 075-753-9477
Email nakayama.takeo.4a@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuko Ikeda
Organization Kyoto University Graduate School of Medicine
Division name Health Informatics
Zip code
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
TEL 075-753-9477
Homepage URL
Email ikeda.yasuko.48x@kyoto-u.jp

Sponsor
Institute Kyoto University
School of Public Health/Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyoto university Clinical Biostatistics Course REDCap
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 医療法人清仁会シミズ病院(京都府), 日本赤十字社和歌山医療センター(和歌山県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 30 Day
Date of IRB
2018 Year 07 Month 31 Day
Anticipated trial start date
2019 Year 01 Month 04 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information <Observational period before education>
Based on existing guidelines and standards (CDC guideline etc.), we will prepare a list of reasons for proper placement of urinary catheter in stroke care.In the consolidation of expert opinion the list for this study will be comprehensive and suitable for the clinical practice situation. Using the list of complete version, the observers (several specialized doctors and nurses at each medical institution) will evaluate each day whether the reason of the urinary indwelling catheterization is appropriate/inappropriate. The occurrence of CAUTI and urinary retention will be recorded. During this period, the education about urinary catheter management for CAUTI prevention will not be given to the medical staffs (doctors and nurses who will take care stroke patients) other than the observers.

<Educational period and observational period after education>
We will have a lecture about appropriate use of urinary catheter to the medical staffs and develop a system to recommend the removal of inappropriate urinary catheter. After two months of educational period, we will compare the proportion of appropriate/inappropriate catheter utilization and the incidence of CAUTI and urinary retention.

Management information
Registered date
2018 Year 07 Month 30 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.