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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Suspended |
Unique ID issued by UMIN | UMIN000046649 |
Receipt No. | 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 | 2022/01/16 |
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 |
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Condition | ||
Condition | end-stage renal disease | |
Classification by specialty |
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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
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Key secondary outcomes | cardiovascular death, infectious disease death and cancer death after selection (February to September 2011) to January 2017
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | Under 20 years of age
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Second Department of Internal Medicine, University of Toyama |
Institute | |
Department |
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 |
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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 | Suspended | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | The prognostic study of 193 patients enrolled between February 2011 and September 2011 is ongoing. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | 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 |