UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036904
Receipt number R000042057
Scientific Title Correlation of delirium with oxidative stress of sepsis patients
Date of disclosure of the study information 2019/05/31
Last modified on 2019/05/31 00:38:52

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Basic information

Public title

Correlation of delirium with oxidative stress of sepsis patients

Acronym

Correlation of delirium with oxidative stress of sepsis patients

Scientific Title

Correlation of delirium with oxidative stress of sepsis patients

Scientific Title:Acronym

Correlation of delirium with oxidative stress of sepsis patients

Region

Japan Asia(except Japan) North America
South America Australia Europe
Africa


Condition

Condition

sepsis

Classification by specialty

Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the association between oxidative stress of sepsis patients and delirium

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Plasma vitamin C concentration and 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

sepsis patients

Key exclusion criteria

none

Target sample size

20


Research contact person

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

Name of contact person

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

Homepage URL


Email

kuribayashi@oita-u-ac.jp


Sponsor or person

Institute

Tsurumi Hospital

Institute

Department

Personal name



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)



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 05 Month 31 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042057


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name