UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000419 |
|---|---|
| Receipt number | 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 21:24:32 |
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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
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
suyama@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000512
