UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Is imbalance of perioperative central and peripheral clock gene in postoperative ill patients association with prognosis?
Title of the study (Brief title)	Is imbalance of perioperative central and peripheral clock gene in postoperative ill patients association with prognosis?
Region	Japan

Condition
Condition	elective surgery
Classification by specialty	Anesthesiology Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To determine whether imbalance of perioperative central and peripheral clock gene in postoperative ill patients association with prognosis
Basic objectives2	Others
Basic objectives -Others	epidemiology research
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	postoperative delirium
Key secondary outcomes	1) hospital mortality, postoperative day 28 mortality, postoperative day 90 mortality 2) ICU stay, ventilator free day 3) postoperative complications

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	1) patients who have undergone elective surgery with general anesthesia and are expected to require postoperative intensive care from February,2016 to March,2017 2) patients who are expected to require postoperative intensive care for more than 48 hours 3) patients over 20 years at the time of obtaining informed consent 4) patients who are able to obtain consent
Key exclusion criteria	1) emergency surgery 2) history of dementia and psychosis 3) female patients with pregnancy or suspected pregnancy 4) patients diagnosed with delirium preoperatively 5) patinets whom research investigator has determined to be inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Kazumi Funaki
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Email	funapon1116@gmail.com

Public contact
Name of contact person	Kazumi Funaki
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Homepage URL
Email	funapon1116@gmail.com

Sponsor
Institute	Division of Anesthesiology and Critical Care Medicin, Tottori University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 02 Month 26 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 13 Day
Anticipated trial start date	2016 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Patients who have undergone elective surgery with general anesthesia and are expected to require postoperative intensive care are included. This study is conducted from February 2016 to March 2017. The relationships between the imbalance of perioperative central and peripheral clock gene and prognosis will be clarified.

Management information
Registered date	2016 Year 02 Month 25 Day
Last modified on	2017 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022759