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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034937
Receipt No. R000039837
Official scientific title of the study 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 2018/11/19

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Basic information
Official scientific title of the study Effects of various dialysates on electrolytes, cardiovascular system, hospitalization rate, life prognosis
Title of the study (Brief title) 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 Tanaka Yusaku
Organization Kawashima Hospital
Division name Clinical Engineering
Address Tokushima Prefecture Tokushima city Kita-sako 1 st town 1-39
TEL 088-631-0110
Email yu-tanaka0724@khg.or.jp

Public contact
Name of contact person Tanaka Yusaku
Organization Kawashima Hospital
Division name Clinical Engineering
Address Tokushima Prefecture Tokushima city Kita-sako 1 st town 1-39
TEL 088-631-0110
Homepage URL
Email yu-tanaka0724@khg.or.jp

Sponsor
Institute Kawashima Hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information nothing special

Management information
Registered date
2018 Year 11 Month 19 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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