UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044708 |
|---|---|
| Receipt number | R000051064 |
| Scientific Title | Daily change of ultrafiltration volume in patients with combination therapy for peritoneal dialysis and hemodialysis |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2024/09/02 20:02:51 |
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Basic information
Public title
Daily change of ultrafiltration volume in patients with combination therapy for peritoneal dialysis and hemodialysis
Acronym
Daily change of ultrafiltration volume in PD+HD therapy
Scientific Title
Daily change of ultrafiltration volume in patients with combination therapy for peritoneal dialysis and hemodialysis
Scientific Title:Acronym
Daily change of ultrafiltration volume in PD+HD therapy
Region
| Japan |
Condition
Condition
patients with combination therapy for peritoneal dialysis and hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the factor for influence daily change of ultrafiltration volume in PD+HD therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
daily change of ultrafiltration volume by peritoneal dialysis
Key secondary outcomes
daily change of ultrafiltration volume by glucose dialysate, daily change of ultrafiltration volume by icodextrin dialysate, patients background, CTR, BNP, blood pressure, D/P Cr, D/D0 Glu, Alb, CRP, Na
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with combination therapy for peritoneal dialysis and hemodialysis
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Toda |
Organization
Kansai Electric Power Hospital
Division name
Nephrology
Zip code
553-0003
Address
2-1-7, Fukushima, Fukushima-ku 54
TEL
+81-6-6458-5821
natoda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohro |
| Middle name | |
| Last name | Toda |
Organization
Kansai Electric Power Hospital
Division name
Nephrology
Zip code
553-0003
Address
2-1-7, Fukushima, Fukushima-ku 54
TEL
+81-6-6458-5821
Homepage URL
natoda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics community of Kansai Electric Power Hospital
Address
2-1-7, Fukushima, Fukushima-ku 54
Tel
+81-6-6458-5821
natoda@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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1111/1744-9987.14205
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/1744-9987.14205
Number of participants that the trial has enrolled
25
Results
The total ultrafiltration volume and the ultrafiltration volume of glucose dialysate after HD increased from 970 to 1151 (p < 0.01) and
from 576 to 750(p < 0.01), respectively, compared with before HD. In contrast, the ultrafiltration volume of icodextrin dialysate did not
change (from 470 to 494, p = 0.40).
Results date posted
| 2024 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 56.5, 8 (32%) patients were women,12 (48%) patients were diabetic, the median PD duration was 58 months, and the median hybrid dialysis duration was 10 months.
Participant flow
Exclusion criteria were patients under 18 years old, treated with more than two HD sessions per week, and unable to record
ultrafiltration volume.
Adverse events
none
Outcome measures
The primary outcome measure of the present study was the change in peritoneal ultrafiltration volume between before HD and after HD
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051064
