UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043679 |
|---|---|
| Receipt number | R000049659 |
| Scientific Title | Involvement of low salt intake in long-term mortality in hemodialysis patients: a retrospective cohort study |
| Date of disclosure of the study information | 2021/03/24 |
| Last modified on | 2021/03/24 11:31:32 |
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Basic information
Public title
Involvement of low salt intake in long-term mortality in hemodialysis patients: a retrospective cohort study
Acronym
Involvement of low salt intake in long-term mortality in hemodialysis patients: a retrospective cohort study
Scientific Title
Involvement of low salt intake in long-term mortality in hemodialysis patients: a retrospective cohort study
Scientific Title:Acronym
Involvement of low salt intake in long-term mortality in hemodialysis patients: a retrospective cohort study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the association between salt intake and mortality in hemodialysis patients.
Basic objectives2
Others
Basic objectives -Others
Clinical relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between salt intake and 4-year mortality in hemodialysis patients.
Key secondary outcomes
Incidence of acute myocardial infarction, unstable angina, heart failure requiring hospitalization, coronary artery revascularization, stroke or cardiac sudden death in 4-year.
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who had been undergoing hemodialysis for at least 2 years at baseline.
Key exclusion criteria
(1) Patients on peritoneal dialysis, (2) frequency of hemodialysis was less than 3 times weekly, (3) CRP was 1.0 mg/dL or higher, and (4) patients with baseline salt intake below the 0.5 or above the 99.5 percentile.
Target sample size
492
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Toujinkai Hospital
Division name
Division of Clinical engineering
Zip code
612-8026
Address
83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
TEL
075-622-1991
key.9629@gmail.com
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Toujinkai Hospital
Division name
Division of Clinical engineering
Zip code
612-8026
Address
83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
TEL
075-622-1991
Homepage URL
key.9629@gmail.com
Sponsor or person
Institute
Tojinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
Tojinkai Hospital
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
Toujinkai Hospital
Address
83-1, Iga, Momoyama-cho, Fushimi-ku, Kyoto 612-8026, Japan
Tel
075-622-1991
key.9629@gmail.com
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
| 2021 | Year | 03 | Month | 24 | 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
492
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
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present study included 492 patients who underwent hemodialysis from June 1st 2016 to May 31st 2020. Corrected salt intake by ideal body weight was the main predictor of outcomes. Ideal body weight was calculated assuming that the ideal body mass index is 22 kg/m2 for the Japanese population. We grouped patients by the interquartile range of corrected salt intake: Q1 (< 0.13 g/kg/day), Q2 (0.13- < 0.16 g/kg/day), Q3 (0.16- < 0.20 g/kg/day), and Q4 (> 0.20 g/kg/day). The multivariate Cox proportional hazards model was used to determine the association between corrected salt intake and mortality, adjusting for potential confounders. The outcomes considered were all-cause mortality and cumulative incidence of cardiovascular events at year 4.
Management information
Registered date
| 2021 | Year | 03 | Month | 19 | Day |
Last modified on
| 2021 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049659
