UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033557
Receipt number 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 2022/08/03 14:52:06

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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 inappropriate 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 total UTI and 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, urostomy, or no urine due to dialysis prior to the onset of stroke

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Takeo
Middle name
Last name Nakayama

Organization

Kyoto University School of Public Health

Division name

Health Informatics

Zip code

606-8501

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 Yasuko
Middle name
Last name Ikeda

Organization

Kyoto University Graduate School of Medicine

Division name

Health Informatics

Zip code

606-8501

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

TEL

075-753-9477

Homepage URL


Email

ikeda.yasuko.48x@kyoto-u.jp


Sponsor or person

Institute

Kyoto University
School of Public Health/Graduate School of Medicine

Institute

Department

Personal name



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

Kyoto University Graduate School and Faculty of Medicine, Ethics Committe

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

0757534680

Email

ethcom@kuhp.kyoto-u.ac.jp


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), 市立福知山市民病院(京都府)


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 24 Day


Related information

URL releasing protocol

not published

Publication of results

Partially published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/epdf/10.1111/jep.13626

Number of participants that the trial has enrolled

738

Results

Inappropriate IUC use decreased from 50.1% in the baseline phase to 22.5% in the implementation phase (absolute risk reduction in interrupted time series analysis 42.4% [95% confidence interval, 19.2%-65.6%]). The device utilization ratio decreased from 0.302 to 0.194 (p < 0.001), whereas CAUTI did not change significantly (from 8.81 to 8.28 per 1000 catheter-days; incidence rate ratio 0.95 [0.44-1.94]). All symptomatic UTI decreased from 9.5% to 4.9% (p = 0.015), with no increase in urinary retention.

Results date posted

2022 Year 08 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

A total of 738 patients in the baseline and implementation phases were analyzed. The mean age was 74.1 and 74.4 years; men accounted for 55.6% and 52.6%; stroke types were cerebral infarction 67.2% and 68.0%, cerebral hemorrhage 25.2% and 25.2%, and subarachnoid hemorrhage 7.6% and 6.8% respectively.

Participant flow

Among 976 patients who met the inclusion criteria, 738 were analysed excluding patients due to use of indwelling urinary catheter, intermittent urinary catheter or urostomy prior to stroke onset; impossible to void for dialysis; and patients admitted during the educational phase.

Adverse events

no adverse events

Outcome measures

The proportion of inappropriate IUC use decreased from 50.1% in baseline cases to 22.5% in implementation cases (p < 0.001). ITS analysis showed a level change with a decrease in inappropriate IUC use (absolute risk reduction [95% confidence interval]: 42.4% [19.2-65.6%]) immediately after the program.
Concerning secondary outcomes for effectiveness, the device utilization ratio decreased from 0.302 to 0.194 (p < 0.001), whereas the incidence rate of CAUTI did not change significantly (from 8.81 to 8.28 per 1000 catheter-days; incidence rate ratio 0.95 [0.44-1.94]). For safety, the incidence proportion of symptomatic UTI significantly decreased from 9.5% to 4.9% (p = 0.015), and the incidence proportion of urinary retention during hospitalization decreased from 17.1% to 12.8% (p = 0.11). The incidence proportion of urinary retention at discharge also decreased from 7.5% to 5.7% (p = 0.33).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2022 Year 08 Month 03 Day



Link to view the page

Value
https://center6.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