UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024783
Receipt number R000028512
Scientific Title The Current of Frailty in Patients with Chronic Hemodialysis
Date of disclosure of the study information 2016/11/10
Last modified on 2017/11/14 13:22:50

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Basic information

Public title

The Current of Frailty in Patients with Chronic Hemodialysis

Acronym

Frailty in Hemodialysis Patients

Scientific Title

The Current of Frailty in Patients with Chronic Hemodialysis

Scientific Title:Acronym

Frailty in Hemodialysis Patients

Region

Japan


Condition

Condition

Frailty

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The ESRD population is also aging worldwide, particularly in Japan. Mean age of all Japanese prevalent ESRD populations is 67.2 years and 61.8 percent of patients were 65 years old and above, and 30.3 percent were 75 years old and above at the end of 2013. According to the Fried definition, the frailty status has been documented in 7 percent of elderly population, 14 percent of CKD patients without dialysis and 42 percent of hemodialysis (HD) adult ESRD patients. Japanese elderly populations and CKD patients at frailty status are almost comparable with above-mentioned prevalence. However, the status of frailty in Japanese HD patients remains unknown.
The purpose of this study is to identify the prevalence and predictors of frailty in Japanese HD patients.

Basic objectives2

Others

Basic objectives -Others

the comparison of frailty between elderly and non-elderly

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

the prevalence of frailty in patients with hemodialysis

Key secondary outcomes

the predictors of frailty


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

The subjects were all chronic HD patients who regularly visited the institutions within the period of this study, and who agreed with the aim and protocol of the present study.

Key exclusion criteria

The initial exclusion criteria were: refusal to participate, hospitalization due to accidents or sickness, and patients with difficulties to answer the questionnaire. Finally, we excluded participants who did not fill the frailty contents in questionnaire completely, from those remaining after initial exclusion.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhito A. Uchida

Organization

Okayama University

Division name

Department of Nephrology, Rheumatology, Endocrinology and Metabolism

Zip code


Address

2-5-1 SHIKATA-CHO KITA-KU, Okayama 700-8558, Japan

TEL

086-235-7235

Email

hauchida@okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruhito A. Uchida

Organization

Okayama University

Division name

Department of Nephrology, Rheumatology, Endocrinology and Metabolism

Zip code


Address

2-5-1 SHIKATA-CHO KITA-KU, Okayama 700-8558, Japan

TEL

086-235-7235

Homepage URL


Email

hauchida@okayama-u.ac.jp


Sponsor or person

Institute

Department of Medicine, Innnoshima General Hospital, Hiroshima, Japan

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nippon Kokan Fukuyama Hospital, Sumitomo Besshi Hospital, Mihara Shiromachi Hospital, Akaiwa Ishikai Hospital and Sugimoto Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

因島総合病院(広島県)、日本鋼管福山病院(広島県)、住友別子病院(愛媛県)、三原城町病院(広島県)、赤磐医師会病院(岡山県)、杉本クリニック(岡山県)


Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Of the 542 patients visiting each institution, 388 were enrolled in this study. In total, 26.0 percent of participants were categorized as not-frailty, 52.6 percent as pre-frailty and 21.4 percent as frailty. The prevalence of frailty increased steadily with age and was more prevalent in females than in males and the subjects with frailty received polypharmacy. A multivariate logistic regression analysis revealed that the factors independently associated with frailty were the following: female gender (OR 3.661), age (OR 1.065), age above 75 years old (OR 4.892), body mass index (BMI) bellow 18.5 (OR 0.110), number of medications being taken (OR 1.351), diabetes mellitus (DM) (OR 2.765) and MNA-SF bellow 11 (OR 7.405). Frailty was associated with the accumulation of risk factors.

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

2015 Year 08 Month 17 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2016 Year 01 Month 31 Day

Date of closure to data entry

2017 Year 11 Month 13 Day

Date trial data considered complete

2017 Year 11 Month 13 Day

Date analysis concluded

2017 Year 11 Month 13 Day


Other

Other related information

This result will be published on the "Aging and Disease" in Februaly 2018.
The detail is placed on bellow URL.
http://www.aginganddisease.org/EN/10.14336/AD.2017.0429


Management information

Registered date

2016 Year 11 Month 10 Day

Last modified on

2017 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028512


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name