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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000419
Receipt No. R000000512
Scientific Title Sodium Bicarbonate Infusion at Low Concentration to Reduce Kidney Insufficiency by Angiographic Non-iodinated Contrast Media
Date of disclosure of the study information 2006/05/16
Last modified on 2007/06/07

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Basic information
Public title Sodium Bicarbonate Infusion at Low Concentration to Reduce Kidney Insufficiency by Angiographic Non-iodinated Contrast Media
Acronym BLOCKADE
Scientific Title Sodium Bicarbonate Infusion at Low Concentration to Reduce Kidney Insufficiency by Angiographic Non-iodinated Contrast Media
Scientific Title:Acronym BLOCKADE
Region
Japan

Condition
Condition Contrast-Induced Nephropathy
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to compare the incidence of contrast-induced nephropathy with sodium bicarbonate or sodium chloride in patients with moderate renal insufficiency
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes the incidence of contrast-induced nephropathy within 2 days of coronary angiography
Key secondary outcomes the incidence of adverse events, the change of glomerular filtration rate in one year and the occurrence of clinical events within one year of coronary angiography

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 administer 154 mEq/L of sodium bicarbonate intravenously, as a bolus of 3 mL/kg/hr for 1 hour before coronary angiography, followed by an infusion of 1 mL/kg/hr for 6 hours after coronary angiography
Interventions/Control_2 administer 0.9% saline intravenously at 1 mL/kg/hr for 12 hours before through 12 hours after coronary angiography
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria individuals with moderate renal insufficiency (serum creatinine concentration exceeding 1.2 mg/dL within 3 months) who are scheduled for coronary angiography
Key exclusion criteria individuals with preexisting dialysis, anticipated dialysis after coronary angiography, acute coronary syndrome, emergency catheterization, overt congestive heart failure, administration of contrast within the previous 3 days and anticipated readministration of contrast following 3 days
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL 075-751-4254
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tamaki Suyama
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, 606-8507, JAPAN
TEL 075-751-4255
Homepage URL
Email suyama@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2006 Year 05 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
Date of protocol fixation
2006 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2008 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 05 Month 14 Day
Last modified on
2007 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000512

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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