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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019276
Receipt No. R000021958
Scientific Title The investigation of an association between body fat mass and thermal effect.
Date of disclosure of the study information 2015/10/08
Last modified on 2016/11/09

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Basic information
Public title The investigation of an association between body fat mass and thermal effect.
Acronym The investigation of an association between body fat mass and thermal effect.
Scientific Title The investigation of an association between body fat mass and thermal effect.
Scientific Title:Acronym The investigation of an association between body fat mass and thermal effect.
Region
Japan

Condition
Condition Living donor of kidney transplantation
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate a correlation between body fat mass and a rise in body temperature.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Correlation of body fat and the body temperature rises
Key secondary outcomes Amount of bleeding, length of hospital stay, postoperative infection

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
70 years-old >
Gender Male and Female
Key inclusion criteria Obtaining patient's informed consent to participate in this study
Key exclusion criteria Emergency operation
ASA physical status >=4
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumio Hoka
Organization Kyushu University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL +81926425714
Email shoka@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryohei Miyazaki
Organization Kyushu University Hospital
Division name Operating rooms
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL +81926425714
Homepage URL
Email miyaryou@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Critical Care Medicine
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 08 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
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 Open public recruiting
Date of protocol fixation
2015 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research perticipants: All donors who undergo laparoscopic donor nephrectomy for kidney transplantation at Kyushu University Hospital from October 2015.
We investigate the correlation between body fat and warming effect of forced air warming device.

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2016 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021958

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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