UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021213 |
|---|---|
| Receipt number | R000022759 |
| Scientific Title | Is imbalance of perioperative central and peripheral clock gene in postoperative ill patients association with prognosis? |
| Date of disclosure of the study information | 2016/02/26 |
| Last modified on | 2017/04/04 04:41:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Is imbalance of perioperative central and peripheral clock gene in postoperative ill patients association with prognosis?
Acronym
Is imbalance of perioperative central and peripheral clock gene in postoperative ill patients association with prognosis?
Scientific Title
Is imbalance of perioperative central and peripheral clock gene in postoperative ill patients association with prognosis?
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazumi Funaki |
Organization
Tottori University
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6657
funapon1116@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Funaki |
Organization
Tottori University
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6657
Homepage URL
funapon1116@gmail.com
Sponsor or person
Institute
Division of Anesthesiology and Critical Care Medicin, Tottori University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022759
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
