UMIN-CTR Clinical Trial

Basic information
Public title	relationship between perioperative oxidative stress and postoperative acute kidney injury
Acronym	OSPAK
Scientific Title	relationship between perioperative oxidative stress and postoperative acute kidney injury
Scientific Title:Acronym	OSPAK
Region	Japan

Condition
Condition	acute kidney injury
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationship between perioperative oxidative stress and postoperative AKI
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative AKI
Key secondary outcomes

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	Patients undergo surgery with general anesthesia, and ASA PS 1-3.
Key exclusion criteria	women before menopause
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Naoji Middle name Last name Mita
Organization	Tokushima University Hospital
Division name	Anesthesiology
Zip code	770-8503
Address	2-50-1, Kuramoto-tyo, Tokushima, Japan
TEL	088-633-7181
Email	mita@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Naoji Middle name Last name Mita
Organization	Tokushima University
Division name	Anesthesiology
Zip code	770-8503
Address	2-50-1, Kuramoto-tyo, Tokushima, Japan
TEL	088-633-7181
Homepage URL
Email	mita@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board,Tokushima University Hospital
Address	2-50-1, Kuramoto-tyo, Tokushima, Japan
Tel	088-633-9294
Email	first-ec@tokushima-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	2015 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	60
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	Main results already published
Date of protocol fixation	2015 Year 11 Month 10 Day
Date of IRB	2016 Year 02 Month 03 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	evaluate the relationship between perioperative oxidative stress and postoperative acute kidney injury

Management information
Registered date	2015 Year 11 Month 10 Day
Last modified on	2019 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022789