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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042871
Receipt No. R000048934
Scientific Title The study of risk factors and prophylactic management of non-oliguric hyperkalemia
Date of disclosure of the study information 2020/12/28
Last modified on 2020/12/28

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Basic information
Public title The study of risk factors and management of non-oliguric hyperkalemia
Acronym RAMNOHK
Scientific Title The study of risk factors and prophylactic management of non-oliguric hyperkalemia
Scientific Title:Acronym RAMNOHK
Region
Japan

Condition
Condition non-oliguric hyperkalemia
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the risk and manage management of non-oliguric hyperkalemia
Basic objectives2 Others
Basic objectives -Others To study the association between non-oliguric hyperkalemia and mortality or neurological impairment
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes non-oliguric hyperkalemia
Key secondary outcomes mortality
neurological impairment

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
1 days-old <=
Age-upper limit
3 days-old >=
Gender Male and Female
Key inclusion criteria Infants with < 32 weeks of gestation admitted between 1999 and 2018 to neonatal intensive care unit in Tokushima University Hospital
Key exclusion criteria chromosome abnormalities
major malformations
missing K value within 72 hours of life
outborn
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Suga
Organization Tokushima University Hospital
Division name Pediatrics
Zip code 7708539
Address Kuramotocho 2-50-1, Tokushima
TEL +81-88-633-9335
Email suga.kenichi.1@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Suga
Organization Tokushima University Hospital
Division name Pediatrics
Zip code 7708503
Address Kuramotocho 2-50-1, Tokushima
TEL +81-88-633-9335
Homepage URL
Email suga.kenichi.1@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Tokushima University
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 Tokushima University Hospital Institutional Review Board
Address Kuramotocho 2-50-1, Tokushima, Tokushima, Japan
Tel +81-88-633-9294
Email awachiken@tokushima-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
2020 Year 12 Month 28 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 480
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
2019 Year 06 Month 01 Day
Date of IRB
2019 Year 05 Month 30 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 11 Month 30 Day

Other
Other related information Early amino acid supplementation significantly reduced the risk of non-oliguric hyperkalemia

Management information
Registered date
2020 Year 12 Month 28 Day
Last modified on
2020 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048934

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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