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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name