UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006896 |
|---|---|
| Receipt number | R000008145 |
| Scientific Title | Incidence of contrast induced nephropathy,comparison of sodium chloride and sodium bicarbonate |
| Date of disclosure of the study information | 2011/12/16 |
| Last modified on | 2018/06/22 08:40:21 |
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Basic information
Public title
Incidence of contrast induced nephropathy,comparison of sodium chloride and sodium bicarbonate
Acronym
prevention of contrast induced nephropathy
Scientific Title
Incidence of contrast induced nephropathy,comparison of sodium chloride and sodium bicarbonate
Scientific Title:Acronym
prevention of contrast induced nephropathy
Region
| Japan |
Condition
Condition
contrast induced nephropathy
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effect of sodium bicarbonate on contrast induced nephropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
contrast induced nephropathy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
sodium bicarbonate
Interventions/Control_2
sodium chloride
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
diabetes mellitus
eGFR under 60
Key exclusion criteria
emergency
hypermagnesemia
hypothyroidism
dialysis
congestive hert failure
NSAIDs(except aspirin)
ineligible patient
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Noma |
Organization
Kagawa Medical School Hospital
Division name
cardiorenal cerebrovascular medicine
Zip code
Address
1750 Ikenobe, Miki-cho,Kida-gun,Kagawa
TEL
087-898-5111
noma@kms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Takabatake |
Organization
cardiorenal cerebrovascular medicine
Division name
cardiology
Zip code
Address
1750 Ikenobe, Miki-cho,Kida-gun,Kagawa
TEL
087-898-5111
Homepage URL
ping_per72_mizuno@yahoo.co.jp
Sponsor or person
Institute
Kagawa Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa Medical School Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 16 | Day |
Last modified on
| 2018 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008145
