UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000043241 |
|---|---|
| Receipt number | R000049351 |
| Scientific Title | Effect of cognitive impairment and assisted PD on adverse event in older patients undergoing peritoneal dialysis. |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2023/05/13 11:10:18 |
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Basic information
Public title
Effect of cognitive impairment and assisted PD on adverse event in older patients undergoing peritoneal dialysis.
Acronym
Effect of cognitive impairment and assisted PD on adverse event in older patients undergoing peritoneal dialysis.
Scientific Title
Effect of cognitive impairment and assisted PD on adverse event in older patients undergoing peritoneal dialysis.
Scientific Title:Acronym
Effect of cognitive impairment and assisted PD on adverse event in older patients undergoing peritoneal dialysis.
Region
| Japan |
Condition
Condition
End stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the risk of adverse event in older patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
over all mortality
Key secondary outcomes
technical failure, peritonitis, exit-cite infection, hospitalization
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
| 65 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) over 65 years old; (2) had been on PD for at least three months; (3) clinically stable
Key exclusion criteria
(1) peritonitis or other severe infection needing intravenous antibiotic use, trauma, operation during 30 days preceding enrolment; (2) history of stroke or amputation; (3) expected to cease PD within 6-month; (4) hospitalized within the previous three months; (5) cognitive impairment that difficult to understand evaluation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yabe |
Organization
Seirei Christopher University
Division name
Department of Physical therapy
Zip code
433-8558
Address
3453 Mikatahara, kita-ku, Hamamatsu, Shizuoka
TEL
0534391400
yabe0909@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yabe |
Organization
Seirei Christopher University
Division name
Department of Physical therapy
Zip code
433-8558
Address
3453 Mikatahara, kita-ku, Hamamatsu, Shizuoka
TEL
0534391400
Homepage URL
yabe0909@gmail.com
Sponsor or person
Institute
Seirei christopher university
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nagoya Kyoritsu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Christopher University
Address
3453 Mikatahara3453, Kita-ku Hamamatsu
Tel
09035886425
yabe0909@gmail.com
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
名古屋共立病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10157-022-02199-9
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10157-022-02199-9
Number of participants that the trial has enrolled
40
Results
Six and 16 patients experienced peritonitis and exit-site infection during follow-up, respectively. Kaplan-Meier analysis and log-rank tests revealed that the without CI and without assistance group was significantly associated with exit-site infection.
Results date posted
| 2022 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median MoCA-J score was 21 points, and 25 patients performed the exit-site care procedure with assistance from their family members. As a result of grouping, 8, 8, and 17 patients were assigned to the without CI and without assistance, without CI and with assistance, and with CI and with assistance groups, respectively.
Participant flow
Among the 40 patients screened, six did not consent to participate in the study and one patient could not understand the evaluation due to dementia. Hence, 33 patients were finally included in the analysis.
Adverse events
The incidence rates of peritonitis were 0.01 in the overall population, 0 in the without CI and without assistance group, 0.02 in the without CI and with assistance group, and 0.01 in the with CI and with assistance group. The incidence rate of exit-site infections was 0.46 in the overall population, 1.63 in the without CI and without assistance group, 0.49 in the without CI and with assistance group, and 0.21 in the with CI and with assistance group. Tunnel infections associated with exit-site infections were suspected in two patients.
Outcome measures
Japanese version of the Montreal Cognitive Assessment (MoCA-J)
exit-site infection
Peritonitis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
enrolled between 1 April 2017 and 31 December 2018
Management information
Registered date
| 2021 | Year | 02 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049351
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