UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003390 |
|---|---|
| Receipt number | R000004115 |
| Scientific Title | Evaluation of effectiveness and safety of hemofilter "Excelflo"(AEF) by continuous hemofiltration treatment for patients who suffer from acute renal failure. |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2012/06/29 10:42:54 |
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Basic information
Public title
Evaluation of effectiveness and safety of hemofilter "Excelflo"(AEF) by continuous hemofiltration treatment for patients who suffer from acute renal failure.
Acronym
Evaluation of effectiveness of hemofilter "EXCELFLO"
Scientific Title
Evaluation of effectiveness and safety of hemofilter "Excelflo"(AEF) by continuous hemofiltration treatment for patients who suffer from acute renal failure.
Scientific Title:Acronym
Evaluation of effectiveness of hemofilter "EXCELFLO"
Region
| Japan |
Condition
Condition
SIRS patients who suffer from acute renal failure
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparative study of continuous hemofilter "EXCELFLO" effectiveness of filtration periods, biocompatibility, and the safety of PANFLO-APF by continuous hemodiafiltration treatment (CHDF).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of adsorbed LDH and fiburin on the membrane after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
EXCELFLO - PANFLO
Interventions/Control_2
PANFLO - EXCELFLO
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are 16 years of age and older who suffer from acute renal failure and SIRS.
Key exclusion criteria
1.Patients who are pregnant or maybe pregnant.
2.Children under 15 years of age.
3.Patients who may possibly be at high risk after consulting with a doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahisa Kawashima |
Organization
Kobe University Hospital
Division name
Emergency Critical Care Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city
TEL
078-382-6521
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Hospital
Division name
Emergency Critical Care Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Hospital
Emergency Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Kuraray Medical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 01 | 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 | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | 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
| 2010 | Year | 03 | Month | 28 | Day |
Last modified on
| 2012 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004115
