UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018181 |
|---|---|
| Receipt number | R000021057 |
| Scientific Title | A prospective cohort study of fluid status on prognosis in starting hemodialysis patients in north area of Miyazaki |
| Date of disclosure of the study information | 2015/07/03 |
| Last modified on | 2024/01/08 10:31:17 |
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Basic information
Public title
A prospective cohort study of fluid status on prognosis in starting hemodialysis patients in north area of Miyazaki
Acronym
Fluid status in starting hemodialysis patients
Scientific Title
A prospective cohort study of fluid status on prognosis in starting hemodialysis patients in north area of Miyazaki
Scientific Title:Acronym
Fluid status in starting hemodialysis patients
Region
| Japan |
Condition
Condition
Patients starting hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We used a bio-impedance spectroscopy device, the Body Composition Monitor (BCM) to assess volume status at regular intervals in a cohort study of starting hemodialysis patients. The object of this study is to clarify the relationship between the volume status and prognosis.
Basic objectives2
Others
Basic objectives -Others
Study the relationship between the parameters of nutritional status and outcome.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
all cause mortality
Key secondary outcomes
hospitalization
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients starting hemodialysis Patients with sighed informed concent
Key exclusion criteria
Patients were amputees, had a cardiac pacemaker, were conneced to life-support device. Patients who are inappropriate for this study by physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shouichi |
| Middle name | |
| Last name | Fujimoto |
Organization
Faculty of medicine, University of Miyazaki
Division name
Department of Hemovascular Medicine and Artificial Organs
Zip code
8891692
Address
5200, kihara, Kiyotake, Miyazaki
TEL
0985-85-1510
fujimos@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Toida |
Organization
Faculty of medicine, University of Miyazaki
Division name
Department of Hemovascular Medicine and Artificial Organs
Zip code
8891692
Address
5200, kihara, Kiyotake, Miyazaki
TEL
0985-85-1510
Homepage URL
t.toida@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Department of Hemovascular Medicine and Artificial Organs, Faculty of medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine, University of Miyazaki
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyazaki Prefectural Nobeoka Hospital
Address
2-1-10 Shinkoji, Nobeoka city, Miyazaki
Tel
0982-32-6181
nobeoka-hp@pref.miyazaki.lg.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
県立延岡病院（宮崎県），泉和会千代田病院（宮崎県），おがわクリニック（宮崎県），おおぬきクリニック（宮崎県），延岡クリニック（宮崎県），みやた内科（宮崎県），長沼医院（宮崎県），なかむら内科循環器内科（宮崎県），家村内科（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000021057
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/12/10/3187
Number of participants that the trial has enrolled
142
Results
Serum zinc levels were significantly associated with patients' body composition and nutrition-related indices, including fluid volume, during dialysis induction. The association of serum zinc levels with all-cause mortality and cardiovascular events was unclear.
Results date posted
| 2024 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 12 | Day |
Baseline Characteristics
Incident hemodialysis patients who newly started hemodialysis for end-stage kidney disease.
Participant flow
Subjects comprised 142 patients enrolled between February 2015 and March 2019.
Adverse events
None.
Outcome measures
All-cause mortality and cardiovascular events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No longer recruiting
Management information
Registered date
| 2015 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021057
