UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051312 |
|---|---|
| Receipt number | R000058503 |
| Scientific Title | Comparison of prognosis of peritoneal dialysis patients before and after COVID-19 pandemic in the Department of Nephrology of Nippon Medical School Hospital |
| Date of disclosure of the study information | 2023/06/11 |
| Last modified on | 2023/06/10 09:55:45 |
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Basic information
Public title
Comparison of prognosis of peritoneal dialysis patients before and after COVID-19 pandemic in the Department of Nephrology of Nippon Medical School Hospital
Acronym
Comparison of prognosis of peritoneal dialysis patients before and after COVID-19 pandemic in the Department of Nephrology of Nippon Medical School Hospital
Scientific Title
Comparison of prognosis of peritoneal dialysis patients before and after COVID-19 pandemic in the Department of Nephrology of Nippon Medical School Hospital
Scientific Title:Acronym
Comparison of prognosis of peritoneal dialysis patients before and after COVID-19 pandemic in the Department of Nephrology of Nippon Medical School Hospital
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The number of inductions, complications, and peritonitis of peritoneal dialysis patients at the Department of Nephrology, Nippon Medical School Hospital, before and after the COVID-19 pandemic will be retrospectively collected from medical records to determine what changes have occurred.
The purpose of this study is to examine the changes in the number of inductions and complications of peritoneal dialysis patients before and after the COVID-19 pandemic, and to provide basic data for considering what countermeasures should be taken in the event of future outbreaks of emerging infectious diseases.
Basic objectives2
Others
Basic objectives -Others
prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peritonitis, heart failure, other complications
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who were introduced to peritoneal dialysis at the Department of Nephrology, Nippon Medical School Hospital between January 1, 2017 and December 31, 2022 will be included in the study.
Key exclusion criteria
none
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
y-sakai@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
1138603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
Homepage URL
y-sakai@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
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
Center for Clinical Research, Nippon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
0338222131
nms_fuzokurinri@nms.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
| 2023 | Year | 06 | Month | 11 | 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
| 2023 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A:January 1, 2017 - December 31, 2019
B:January 1, 2020 - December 31, 2022
During each of the above three years, height, weight, blood pressure, history, occurrence of peritonitis, catheter outlet score, and blood sampling data (serum creatinine level, serum BUN level, serum total protein level, serum albumin level, hemoglobin, and CRP) of patients who were inducted into peritoneal dialysis at the Department of Nephrology, Nippon Medical School Hospital, will be collected from medical records and compared retrospectively. The data will be collected from medical records and compared retrospectively.
Management information
Registered date
| 2023 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058503
