UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042871
Receipt number 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 21:50:33

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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 or person

Institute

Tokushima University

Institute

Department

Personal name



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

Value
https://center6.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