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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018805
Receipt No. R000021736
Scientific Title A randomized control trial to prevent perioperative oxidative stress, inflammatory response and multiple organ injury after cardiovascular surgery by intravenous vitamin C: An electron spin resonance study
Date of disclosure of the study information 2015/08/26
Last modified on 2015/08/26

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Basic information
Public title A randomized control trial to prevent perioperative oxidative stress, inflammatory response and multiple organ injury after cardiovascular surgery by intravenous vitamin C: An electron spin resonance study
Acronym A randomized control trial to prevent perioperative oxidative stress, inflammatory response and multiple organ injury after cardiovascular surgery by intravenous vitamin C: An electron spin resonance study
Scientific Title A randomized control trial to prevent perioperative oxidative stress, inflammatory response and multiple organ injury after cardiovascular surgery by intravenous vitamin C: An electron spin resonance study
Scientific Title:Acronym A randomized control trial to prevent perioperative oxidative stress, inflammatory response and multiple organ injury after cardiovascular surgery by intravenous vitamin C: An electron spin resonance study
Region
Japan

Condition
Condition Patients undergoing cardiovascular surgery
Classification by specialty
Anesthesiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess using electron spin resonance spectrometer whether intravenous vitamin C suppresses perioperative oxidative stress, inflammatory response and multiple organ injury after cardiovascular surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes SOFA (sequential organ failure assessment) scores
Key secondary outcomes Cardiac index
Drainage in the First 24 Postoperative Hours
Drainage in ICU
Acute kidney injury
RIFLE criteria
ICU stay
Hospital Stay
Surgical new intervention
reparation
inflammatory markers
oxidative stress markers
stress hormones

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous vitamin C administration during perioperative period of cardiovascular surgery (intraopeative; 1g X 2, postoperative; 0.5g X 2 a day for 5days)
Interventions/Control_2 Intravenous saline administration during perioperative period of cardiovascular surgery
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 undergoing cardiovascular surgery with American Society of Anesthesiologists (ASA) physical status class 1-3
Key exclusion criteria Patients who have hypersensitivity to this agent or similar medicine.
Pregnant patients or patients of child-bearing potential.
Severe hepatopathic patients and severe kidney injury except dialysis patients.
Patients whom the principal investigator judged to be inappropriate as a subject.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigekiyo Matsumoto
Organization Oita University
Division name Anesthesiology
Zip code
Address 1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita-ken
TEL 097-586-5943
Email sigekiyo@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigekiyo Matsumoto
Organization Oita University
Division name Anesthesiology
Zip code
Address 1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita-ken
TEL 097-586-5943
Homepage URL
Email sigekiyo@oita-u.ac.jp

Sponsor
Institute Oita University, Faculty of Medicine, Department of Anesthesiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Oita University, Faculty of Medicine, Department of cardiovascular surgery
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大分大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 08 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 Preinitiation
Date of protocol fixation
2015 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 28 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
2016 Year 07 Month 31 Day
Date analysis concluded
2016 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 26 Day
Last modified on
2015 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021736

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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