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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028172
Receipt No. R000032248
Scientific Title Influence of large amount substitution fluid on electrolyte change
Date of disclosure of the study information 2017/07/11
Last modified on 2017/09/12

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Basic information
Public title Influence of large amount substitution fluid on electrolyte change
Acronym Influence of large amount substitution fluid on electrolyte change
Scientific Title Influence of large amount substitution fluid on electrolyte change
Scientific Title:Acronym Influence of large amount substitution fluid on electrolyte change
Region
Japan

Condition
Condition dialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is a well-known fact that it influences electrolytes such as calcium in the body depending on the composition of the dialysate. In particular, there are also documents that bicarbonate dialysate (Carbosta) has a composition greatly different from that of other dialysate and has a great influence on the electrolyte, which is effective in preventing blood pressure lowering. However, when hemodiafiltration is replenished with a large amount of dialysate, it is not clarified at this time what kind of influence the body's electrolyte will have. We also acknowledge reports that the rapid correction of acidosis has an adverse effect on lower limb swings. Therefore, we used three types of dialysate, Carbosta, Kindari and Linpak this time, and evaluate the change of electrolyte in the body by treatment condition with hemodiafiltration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood ionized calcium
At the start of therapy, 2 hours after the start of treatment, and at the end of treatment, blood test and concentration measurement in dialysis effluent were conducted.
Key secondary outcomes 1. Blood ionized magnesium
2. Blood bicarbonate ion

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Dialysate and replacement fluid amount are changed.
The replacement liquid volume was 60 L and 84 L by the pre-dilution , 8 L and 16 L by the post-dilution.
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

Not applicable
Gender Male and Female
Key inclusion criteria Stable chronic maintenance dialysis patients
Key exclusion criteria Patient with cancer
Patient with CRP where there is remarkable inflammation more than 2
The patient who uses blood catharsis except hemodialysis therapy or the hemodialysis filtration therapy together
During the pregnancy or the patient whom I am nursing
The patient who has a high disability in the liver, a heart, the lungs
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusaku Tanaka
Organization Kawashima Hospital
Division name Clinical department of engineering
Zip code
Address 1-1-39 Kitasako, Tokusima, 770-8548, Japan
TEL 088-631-0110
Email tanakayusaku0724@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yusaku Tanaka
Organization Kawashima Hospital
Division name Clinical department of engineering
Zip code
Address 1-1-39 Kitasako, Tokusima, 770-8548, Japan
TEL 088-631-0110
Homepage URL
Email tanakayusaku0724@gmail.com

Sponsor
Institute Kawashima Hospital
Institute
Department

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
Address
Tel
Email

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
2017 Year 07 Month 11 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 Completed
Date of protocol fixation
2017 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 17 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2017 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032248

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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