UMIN-CTR Clinical Trial

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 Sumio Middle name Last name Hoka
Organization	Kyushu University
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code	8128582
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 Ryohei Middle name Last name Miyazaki
Organization	Kyushu University Hospital
Division name	Operating rooms
Zip code	8128582
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	Kyushu University IRB
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel	+816425714
Email	ijkseimei@jimu.kyushu-u.ac.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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 08 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0218281
Number of participants that the trial has enrolled	104
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	2015 Year 10 Month 08 Day
Date of IRB	2015 Year 10 Month 04 Day
Anticipated trial start date	2015 Year 10 Month 09 Day
Last follow-up date	2018 Year 12 Month 31 Day
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	2019 Year 08 Month 27 Day

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