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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name