UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046649
Receipt number R000053212
Scientific Title A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients
Date of disclosure of the study information 2022/01/16
Last modified on 2022/07/18 22:54:33

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Basic information

Public title

A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients

Acronym

A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients

Scientific Title

A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients

Scientific Title:Acronym

A Study on Life Prediction by Combination of Geriatric Nutritional Risk Index and Modified Creatinine Index in Hemodialysis Patients

Region

Japan


Condition

Condition

end-stage renal disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We hypothesize that the combination of GNRI and modified Cr index can predict life expectancy more sensitively, and the purpose of this study is to conduct a cohort study.

Basic objectives2

Others

Basic objectives -Others

We hypothesize that the combination of GNRI and modified Cr index can predict life expectancy more sensitively, and the purpose of this study is to conduct a cohort study.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

all-cause death after selection (February to September 2011) to January 2017

Key secondary outcomes

cardiovascular death, infectious disease death and cancer death after selection (February to September 2011) to January 2017


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent maintenance hemodialysis at our hospital and research collaborating institutions during the period of February to September 2011
Age 20 years or older

Key exclusion criteria

Under 20 years of age

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tsutomu
Middle name
Last name Koike

Organization

University of Toyama

Division name

Department of Patient Safety and Healthcare Quality

Zip code

930-0194

Address

2630 Sugitani, Toyama 930-0194, Japan

TEL

076-434-7297

Email

tkoike@med.u-toyama.ac.jp


Public contact

Name of contact person

1st name Tsutomu
Middle name
Last name koike

Organization

University of Toyama

Division name

Department of Patient Safety and Healthcare Quality

Zip code

930-0194

Address

2630 Sugitani, Toyama 930-0194, Japan

TEL

076-434-7297

Homepage URL

https://toyama.bvits.com/rinri/publish.aspx

Email

tkoike@med.u-toyama.ac.jp


Sponsor or person

Institute

Second Department of Internal Medicine, University of Toyama

Institute

Department

Personal name



Funding Source

Organization

Second Department of Internal Medicine, University of Toyama

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

University of Toyama

Address

2630 Sugitani, Toyama 930-0194, Japan

Tel

076-415-8857

Email

rinri@adm.u-toyama.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

2022 Year 01 Month 16 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

Terminated

Date of protocol fixation

2011 Year 02 Month 01 Day

Date of IRB

2021 Year 11 Month 29 Day

Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date

2022 Year 06 Month 30 Day

Date of closure to data entry

2022 Year 06 Month 30 Day

Date trial data considered complete

2022 Year 06 Month 30 Day

Date analysis concluded

2022 Year 07 Month 30 Day


Other

Other related information

The prognostic study of 193 patients enrolled between February 2011 and September 2011 is ongoing.


Management information

Registered date

2022 Year 01 Month 16 Day

Last modified on

2022 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053212


Research Plan
Registered date File name
2022/01/16 研究計画書(GNRI, mCI)第3版.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/01/16 repositry_GNRI.csv