UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Incidence of contrast induced nephropathy,comparison of sodium chloride and sodium bicarbonate
Title of the study (Brief title)	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	Takahisa Noma
Organization	Kagawa Medical School Hospital
Division name	cardiorenal cerebrovascular medicine
Address	1750 Ikenobe, Miki-cho,Kida-gun,Kagawa
TEL	087-898-5111
Email	noma@kms.ac.jp

Public contact
Name of contact person	Wataru Takabatake
Organization	cardiorenal cerebrovascular medicine
Division name	cardiology
Address	1750 Ikenobe, Miki-cho,Kida-gun,Kagawa
TEL	087-898-5111
Homepage URL
Email	ping_per72_mizuno@yahoo.co.jp

Sponsor
Institute	Kagawa Medical School Hospital
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 12 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008145