UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034937 |
|---|---|
| Receipt number | R000039837 |
| Scientific Title | Effects of various dialysates on electrolytes, cardiovascular system, hospitalization rate, life prognosis |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2020/11/16 21:50:29 |
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Basic information
Public title
Effects of various dialysates on electrolytes, cardiovascular system, hospitalization rate, life prognosis
Acronym
Influence of use of the same dialysate for a long time
Scientific Title
Effects of various dialysates on electrolytes, cardiovascular system, hospitalization rate, life prognosis
Scientific Title:Acronym
Influence of use of the same dialysate for a long time
Region
| Japan |
Condition
Condition
Hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will retrospectively compare the differences in the effect of using the same dialysate over 3 years, centered on cardiac function and cardiovascular calcification.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality rate
Hospitalization rate, re-hospitalization rate
Corrected Ca, P, intact-PTH, Mg
Abdominal CT:calcification score
Key secondary outcomes
Coronary artery CT: calcification score
Vascular endothelial function (FMD)
Intima-media complex thickness (IMT): upper arm IMT, carotid IMT
ABI
PWV
Echocardiography: left atrium diameter (LAD), left ventricular end diastolic diameter (LADd), left ventricular ejection fraction (EF), extended early wave (e '), expanded early wave / extended early wave (E / e' ), Left ventricular mass coefficient (LVMI), ventricular septal thickness (IVS), left ventricular wall thickness (LVWT)
Electrocardiogram: QTc
Prescription drugs and injections (at the beginning and at the end / at the time of death): phosphorus adsorbents, vitamin D preparations, calcium receptor agonists, Mg-containing preparations
Frequency of dialysis hypotension requiring replacement fluid
Nutritional status: PCR, GNRI,% CGR, BMI, Alb, TP, ChE
Periodic blood collection results: Hb, Ht, BUN, Cre, Na, Cl, Fe, ferritin, blood glucose (GA, HbA1c), B2-MG
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
Patients who continue to use the same dialysate for 3 years or more
Stable maintaining dialysis patient
Key exclusion criteria
Patients with peritoneal dialysis combined
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yusaku |
| Middle name | |
| Last name | Tanaka |
Organization
Kawashima Hospital
Division name
Clinical Engineering
Zip code
7700011
Address
Tokushima Prefecture Tokushima city Kita-sako 1 st town 1-39
TEL
088-631-0110
yu-tanaka0724@khg.or.jp
Public contact
Name of contact person
| 1st name | Yusaku |
| Middle name | |
| Last name | Tanaka |
Organization
Kawashima Hospital
Division name
Clinical Engineering
Zip code
7700011
Address
Tokushima Prefecture Tokushima city Kita-sako 1 st town 1-39
TEL
088-631-0110
Homepage URL
tanakayusaku0724@gmail.com
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawashima 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
Kawashima Hospital
Address
Tokushima Prefecture Tokushima city Kita-sako 1 st town 1-39
Tel
088-631-0110
yu-tanaka0724@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
| 2018 | Year | 12 | Month | 01 | 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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | 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
nothing special
Management information
Registered date
| 2018 | Year | 11 | Month | 19 | Day |
Last modified on
| 2020 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039837
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
