UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018805 |
|---|---|
| Receipt number | 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 10:43:11 |
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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
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
sigekiyo@oita-u.ac.jp
Sponsor or person
Institute
Oita University, Faculty of Medicine, Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021736
