UMIN-CTR Clinical Trial

Basic information
Public title	Correlation of postoperative delirium with oxidative stress of non-cardiac surgery
Acronym	Correlation of postoperative delirium with oxidative stress of non-cardiac surgery
Scientific Title	Correlation of postoperative delirium with oxidative stress of non-cardiac surgery
Scientific Title:Acronym	Correlation of postoperative delirium with oxidative stress of non-cardiac surgery
Region	Japan Asia(except Japan) North America South America Australia Europe Africa

Condition
Condition	non-cardiac surgery
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Dermatology Orthopedics Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the association between perioperative oxidative stress and postoperative delirium following non-cardiac surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma vitamin C concentration and postoperative delirium
Key secondary outcomes	Oxidative stress marker, inflammatory marker and biochemical exam

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	elective non-cardiovascular surgery patients
Key exclusion criteria	none
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Yoshihide Middle name Last name Kuribayashi
Organization	Tsurumi Hospital
Division name	Department of Anesthesiology
Zip code	874-8585
Address	4333 Tsurumi, Beppu City, Oita
TEL	0977-23-7111
Email	kuribayashi@oita-u.ac.jp

Public contact
1st name of contact person	1st name Yoshihid Middle name Last name Kuribayashi
Organization	Tsurumi Hospital
Division name	Department of Anesthesiology
Zip code	874-8585
Address	4333 Tsurumi, Beppu City, Oita
TEL	0977-23-7111
Homepage URL
Email	kuribayashi@oita-u.ac.jp

Sponsor
Institute	Tsurumi Hospital
Institute
Department

Funding Source
Organization	Oita University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tsurumi Hospital
Address	4333 Tsurumi, Beppu City, Oita
Tel	0977-23-7111
Email	kuribayashi@oita-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	2019 Year 05 Month 31 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	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Postoperative delirium (POD) affects approximately 20 - 30 % of patients after cardiovascular surgery and is associated with increased mortality and persistent cognitive decline, and the prevention of POD is a matter of the highest urgency. Patients undergoing cardiac surgery increase the production of reactive oxygen species and induce oxidative injury due to tissue hypoxia, ischemia and hyperoxic reperfusion. Therefore, intraoperative oxidative injury may contribute to postoperative brain injury and subsequent POD. We conducted this study to test the hypothesis that perioperative oxidative stress is associated with the department of POD following cardiac surgery. If the hypothesis holds true, we hope future studies to determine whether interventions that reduce oxidative stress decrease POD.

Management information
Registered date	2019 Year 05 Month 31 Day
Last modified on	2019 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042058