UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003145 |
|---|---|
| Receipt number | R000003814 |
| Scientific Title | Impact of Periprocedural Hemodiafiltration with Blood Suction from the Right Atrium on the Prevention of Contrast-Induced Acute Kidney Injury |
| Date of disclosure of the study information | 2010/02/08 |
| Last modified on | 2012/08/06 17:18:13 |
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Basic information
Public title
Impact of Periprocedural Hemodiafiltration with Blood Suction from the Right Atrium on the Prevention of Contrast-Induced Acute Kidney Injury
Acronym
Periprocedural hemodiafiltration with blood suction from the right atrium
Scientific Title
Impact of Periprocedural Hemodiafiltration with Blood Suction from the Right Atrium on the Prevention of Contrast-Induced Acute Kidney Injury
Scientific Title:Acronym
Periprocedural hemodiafiltration with blood suction from the right atrium
Region
| Japan |
Condition
Condition
contrast induced acute kidney injury
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of hemodiafiltration with blood suction from the right atrium on the prevention of contrast induced acute kidney injury in the patients with severe renal dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of contrast induced acute kidney injury.
Contrast induced acute kidney injury is defined as an increase of serum Cr above 0.3 mg/dL or > 25% within 1 week after exposure to contrast medium.
Key secondary outcomes
Before and after the procedure, we evaluated the serumn and urine markers, such as urinary liver-type fatty acid-binding protein (L-FABP), beta 2-microglobrin (beta2-MG), N-acetyl-beta-D-glucosaminidase (NAG), and serum cystatin C (CysC), beta2-MG, and Creatinine.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
continuous hemodiafiltration(CHDF) with blood-suction from the right atrium
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with severe renal dysfunction (eGFR <45ml/min) undergoing coronary angiography or percutaneous coronary intervention.
(A)age 30 - 90 years old
(B)e-GFR <45ml/min
(C)Patients undergoing coronary procedure
(D)There is no allergy to the contrast medium.
Key exclusion criteria
Exclusion criteria were as follows: acute coronary syndrome, cardiogenic shock, congestive heart failure, pregnancy, dehydration, intravascular administration of contrast medium within the previous 7 days, chronic dialysis, and history of allergy to the contrast medium.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Michishita |
Organization
Yokohama sakae kyosai hospital
Division name
internal medicine
Zip code
Address
132 Katsura-cho, Sakae-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromasa Katoh |
Organization
Yokohama sakae kyosai hospital
Division name
internal medicine
Zip code
Address
TEL
045-891-2171
Homepage URL
Sponsor or person
Institute
Yokohama sakae kyosai hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama sakae kyosai hospital
Organization
Division
Category of Funding Organization
Other
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
国家公務員共済連合組合会 横浜栄共済病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 08 | 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
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 08 | Day |
Last modified on
| 2012 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003814
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| Registered date | File name |
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