UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046359 |
|---|---|
| Receipt number | R000052897 |
| Scientific Title | Verification of the appropriate period from the operation of laparoscopic peritoneal dialysis catheter placement to the start of peritoneal dialysis |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2024/04/27 11:36:04 |
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Basic information
Public title
Verification of the appropriate period from the operation of laparoscopic peritoneal dialysis catheter placement to the start of peritoneal dialysis
Acronym
Verification of the appropriate period from the operation of laparoscopic peritoneal dialysis catheter placement to the start of peritoneal dialysis
Scientific Title
Verification of the appropriate period from the operation of laparoscopic peritoneal dialysis catheter placement to the start of peritoneal dialysis
Scientific Title:Acronym
Verification of the appropriate period from the operation of laparoscopic peritoneal dialysis catheter placement to the start of peritoneal dialysis
Region
| Japan |
Condition
Condition
End-stage renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the appropriate period from the placement of the peritoneal dialysis catheter to the actual start of peritoneal dialysis
Basic objectives2
Others
Basic objectives -Others
Verification of whether safety and efficacy can be ensured even if peritoneal dialysis is started 3 days after the peritoneal dialysis catheter is placed
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Peritoneal dialysis fluid leakage rate within 3 months after the introduction of peritoneal dialysis and peritoneal dialysis catheter exit rate infection rate within 3 months after introduction of peritoneal dialysis
Key secondary outcomes
Rate of outbreak of short-term indwelling catheter infection for hemodialysis and average length of hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A group that starts peritoneal dialysis 7 days after indwelling a peritoneal dialysis catheter
Interventions/Control_2
A group that starts peritoneal dialysis 3 days after indwelling a peritoneal dialysis catheter
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Newly introduced peritoneal dialysis patients at clinical research facility
Key exclusion criteria
Patients who do not wish to participate in clinical research
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Washida |
Organization
International University of Health and Welfare Narita Hospital
Division name
Division of Nephrology
Zip code
286-8520
Address
852 Hatakeda, Narita City, Chiba Prefecture
TEL
0476-35-5600
washida@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Sugita |
Organization
International University of Health and Welfare Hospital
Division name
Division of Nephrology
Zip code
329-2763
Address
537-3 Iguchi, Nasushiobara City, Tochigi Prefecture
TEL
0287-37-2221
Homepage URL
ksugita0425@yahoo.co.jp
Sponsor or person
Institute
Division of Nephrology at International University of Health and Welfare Narita Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology at International University of Health and Welfare Narita Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Ethics Review Board
Address
4-3 Kozunomori, Narita City, Chiba Prefecture
Tel
0476-35-5613
rinri_md@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2021 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052897
