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
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
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
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
