UMIN-CTR Clinical Trial

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
Email	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
Email	tanakayusaku0724@gmail.com

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)

IRB Contact (For public release)
Organization	Kawashima Hospital
Address	Tokushima Prefecture Tokushima city Kita-sako 1 st town 1-39
Tel	088-631-0110
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039837