UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037939 |
|---|---|
| Receipt number | R000043241 |
| Scientific Title | Investigation of the management of long-term indwelling catheter |
| Date of disclosure of the study information | 2019/09/05 |
| Last modified on | 2022/04/09 23:20:49 |
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Basic information
Public title
Investigation of the management of long-term indwelling catheter
Acronym
Investigation of the management of long-term indwelling catheter
Scientific Title
Investigation of the management of long-term indwelling catheter
Scientific Title:Acronym
Investigation of the management of long-term indwelling catheter
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the management of catheter with a lower infection rate.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Catheter infection
2.Presence or absence of catheter outlet infection
3.Incidence of infection
4.Culture tests of infection cases
Key secondary outcomes
1.Reasons for catheter insertion
2.Catheter usage period
3.Age
4.Dialysis vintage
5.Presence or absence of diabetes
6.Past medical history of sepsis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Open management of the catheter outlet
Interventions/Control_2
Closed management of the catheter outlet
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had inserted long-term catheter
Key exclusion criteria
1.Patients who had inserted catheter at other hospitals
2.Patients without agreement on enrolment of this study
3.Inappropriate patients judged by doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Ogawa |
Organization
Kawashima hospital
Division name
Nursing Department
Zip code
770-0011
Address
1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL
0886310110
s.ogawa@khg.or.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Ogawa |
Organization
Kawashima hospital
Division name
Nursing Department
Zip code
770-0011
Address
1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
TEL
0886310110
Homepage URL
s.ogawa@khg.or.jp
Sponsor or person
Institute
Kawashima hospital
Institute
Department
Personal name
Funding Source
Organization
Kawashima hospital
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
Kawashima hospital
Address
1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan
Tel
0886310110
s.ogawa@khg.or.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
