UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation of postoperative delirium with perioperative oxidative stress
Title of the study (Brief title)	Correlation of postoperative delirium with perioperative oxidative stress
Region	Japan

Condition
Condition	cardiac disease
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the association between perioperative oxidative stress and postoperative delirium following 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 cardiovascular surgery patients
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshihide Kuribayashi
Organization	Oita University, Faculty of Medicine
Division name	Department of Anesthesiology
Address	1-1 Idaigaoka, Hasama-machi, Yufu City, Oita 879-5593
TEL	097-586-5943
Email	kuribayashi@oita-u.ac.jp

Public contact
Name of contact person	Yoshihide Kuribayashi
Organization	Oita University, Faculty of Medicine
Division name	Department of Anesthesiology
Address	1-1 Idaigaoka, Hasama-machi, Yufu City, Oita 879-5593
TEL	097-586-5943
Homepage URL
Email	kuribayashi@oita-u.ac.jp

Sponsor
Institute	Oita University
Institute
Department

Funding Source
Organization	Oita University, Faculty of Medicine, Department of Anesthesiology
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 07 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 20 Day
Anticipated trial start date	2017 Year 08 Month 01 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	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	2017 Year 07 Month 28 Day
Last modified on	2017 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032503